scholarly journals Adverse events related to total ankle replacement devices: an analysis of reports to the United States Food and Drug Administration

2021 ◽  
Author(s):  
Karim Mahmoud ◽  
Sreenivasulu Metikala ◽  
Kathryn M. O’Connor ◽  
Daniel C. Farber
Keyword(s):  
The United States ◽  
Control Device ◽  
Mandatory Reporting ◽  
Total Ankle Replacement ◽  
Published Data ◽  
Safety Database ◽  
Ankle Replacement ◽  
United States Food ◽  
User Facility ◽  
Reporting Mechanism

Abstract Background The published outcomes of total ankle replacement (TAR) implants came from limited institutions creating observational bias. For broader perspective, we queried the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) voluntary database to explore complications reported outside published literature. Methods The database was reviewed retrospectively between November 2011 and April 2019 using two product codes assigned to six TAR devices. Results Among 648 relevant reports available in the database, common complications were aseptic loosening (19.3%), infection (18.2%), and alignment/mechanical issues (16.5%). Others included instrument/instrumentation complications, impingement, polyethylene problems, fractures, avascular necrosis of talus (AVN), and packaging issues. Conclusion MAUDE database revealed various patterns of device-related malfunctions that have been under-reported in published data. Despite inconsistency in the available reports, it provided opportunities for improvements in quality control, device design, and ultimately patient safety. Database would be further strengthened by more robust reporting mechanism or mandatory reporting of device-related complications.

scholarly journals Adverse Events in Total Ankle Arthroplasty, Analysis of the FDA Medical and User Facility Device Experience Database

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0028
Author(s):  
Karim Mahmoud ◽  
Sreenivasulu Metikala ◽  
Kathryn O’Connor ◽  
Daniel Farber
Keyword(s):  
Adverse Events ◽  
Aseptic Loosening ◽  
Mandatory Reporting ◽  
Total Ankle Replacement ◽  
Total Ankle Arthroplasty ◽  
Ankle Arthritis ◽  
Ankle Arthroplasty ◽  
Ankle Replacement ◽  
Mode Of Failure ◽  
User Facility

Category: Ankle Arthritis Introduction/Purpose: Total ankle replacement has become a popular treatment option for end stage ankle arthritis. Most of the reports of adverse events following total ankle replacement have been from high volume institutions and are subject to either observational or selection bias as well as potential under-reporting as they do not include the experience of community and lower volume centers and surgeons. The FDA’s Medical and User Facility Device Experience (MAUDE) Database provides a more complete scope of adverse events due to the mandatory reporting requirements by the FDA of implant manufactures. We reviewed the database to identify the common modes of failure and complications of total ankle implants Methods: We retrospectively reviewed reports of the MAUDE database from November 2011 to September 2018 regarding all total ankle implants. Each device in the MAUDE database is classified with a 3-letter code, we identified the 2 codes assigned to total ankle arthroplasty devices, and manually searched the FDA’s published Device Classification list for adverse events. All events were reviewed and classified. Data related to patient age or sex, surgeon, medical center location are not available in the database Results: We identified 1000 adverse reports in the period between November 2011 and September 2018. After exclusion of duplicate reports for single events or reports irrelevant to total ankle arthroplasty, a total of 697 adverse event reports were noted. The most common mode of failure was aseptic loosening (21%), followed by infection (16%), alignment and mechanical issues (instability, malalignment, malposition, stiffness, impingement) (15%), implantation issues (pin, screw or drill breakage, alignment guide problems) (9%), polyethylene related problems (wear, displaced or fractured implants) (7%), bony and soft tissue overgrowth (6%), and peri-prosthetic fractures (5%). Conclusion: Our analysis reveals that the most reported mode of failure was aseptic loosening followed by infection. However, it is notable that there are a significant number of issues with implant alignment and mechanics, complications during implantation and polyethylene component failure that are under-reported in the literature. Knowledge of these adverse events may help surgeons avoid similar complications as well as lead to improvement in component implantation and design

Adverse Events Related to Cartiva Hemiarthroplasty of First Metatarsal: An Analysis of Reports to the United States Food and Drug Administration

2020 ◽  
pp. 193864002094371
Author(s):  
Sreenivasulu Metikala ◽  
Karim Mahmoud ◽  
Kathryn M. O’Connor ◽  
Wen Chao ◽  
Keith L. Wapner ◽  
...  
Keyword(s):  
United States ◽  
Bone Erosion ◽  
Case Series ◽  
The United States ◽  
Hallux Rigidus ◽  
Mandatory Reporting ◽  
True Incidence ◽  
United States Food ◽  
States Food ◽  
Reporting Mechanism

Background: The results supporting Cartiva, a synthetic cartilage implant (Wright Medical) in hallux rigidus have come from limited institutions creating observational bias. Complications experienced in community centers are not routinely included in the published literature. To look at a broader range of potential complications, we reviewed the United States Food and Drug Administration’s (FDA) voluntary device database and compared that data with published literature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database of the FDA was retrospectively reviewed between July 2016 and October 2019 using the product code: PNW, assigned for Cartiva. Results: A total of 49 events have been reported and implant subsidence was the most common with 16 reports. Others include fragmentation (9), infection (4), bone erosion (3), foreign body reaction (1) and unspecified (16). Thirty-five events mentioned further surgeries at a mean interval of 4.75 months. Conclusions: The analysis of the MAUDE database disclosed certain device-related dysfunctions that have been underreported in the published literature. Because of the voluntary nature of reporting, the true incidence of each complication is unknown with this data representing a baseline. The MAUDE database could be further strengthened by a more robust reporting mechanism or mandatory reporting of device-related complications. Levels of Evidence: Level IV: Case series from large database analysis

scholarly journals Perspectives in Treatments of End-Stage Ankle Arthritis Among Orthopaedic Surgeons

2018 ◽  
Vol 3 (3) ◽  
pp. 247301141877997
Author(s):  
Phinit Phisitkul ◽  
Natalie Glass ◽  
Patrick B. Ebeling ◽  
Sandra E. Klein ◽  
Jeffrey E. Johnson
Keyword(s):  
United States ◽  
The United States ◽  
Total Ankle Replacement ◽  
Ankle Arthritis ◽  
Cross Sectional Survey ◽  
Level Of Evidence ◽  
Cross Sectional ◽  
Orthopaedic Surgeons ◽  
Ankle Replacement ◽  
End Stage

Background: This study aimed to assess the preferred operative treatment for patients over the age of 60 with end-stage ankle arthritis and perspectives on total ankle replacement (TAR) among American Orthopaedic Foot & Ankle Society (AOFAS) members. Associated factors were analyzed for potential contraindications among members with different levels of experience. Method: A questionnaire containing 6 questions was designed and sent to 2056 members of the AOFAS. Responses were received from 467 orthopaedic surgeons practicing in the United States (76%), Canada (5%), and 26 other countries (20%). Participants were grouped for response comparisons according to country as well as experience level. Differences in contraindications were compared using χ2 tests or exact tests. Results: Respondents practicing in the United States and surgeons who perform 11 or more TARs per year tended to recommend operative treatments favoring TAR and displayed recognition of its increasing role ( P < .05). Overall, respondents felt that 41% of typical patients over 60 years old with end-stage arthritis would be best treated with TAR. Talus avascular necrosis, morbid obesity (body mass index >40 kg/m2), and poorly controlled diabetes with neuropathy were most recognized as the absolute contraindications to TAR. Surgeon’s experience affected the consideration of these clinical factors as contraindications. Conclusions: Total ankle replacement has a substantial and increasing role in the treatment of end-stage ankle arthritis in patients over the age of 60. Absolute and potential contraindications of the procedures were indicated from a cross-sectional survey of AOFAS members. Surgeons more experienced with total ankle replacement felt more comfortable employing it in a wider range of clinical settings. Level of Evidence: Level III, therapeutic.

scholarly journals Comparing Sports Activity Following Total Ankle Replacement Versus Ankle Arthrodesis

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0003 ◽  
Author(s):  
Seth Richman ◽  
Tyler Rutherford ◽  
Timothy Rearick ◽  
John T. Campbell ◽  
Rebecca Cerrato ◽  
...  
Keyword(s):  
Decision Making ◽  
The United States ◽  
Ankle Arthrodesis ◽  
Total Ankle Replacement ◽  
Activity Level ◽  
Activity Levels ◽  
Sports Activity ◽  
Ankle Replacement ◽  
Foot Function

Category: Ankle, Ankle Arthritis, Sports Introduction/Purpose: Total ankle replacement (TAR) and ankle arthrodesis (AA) are two common surgical treatment modalities for end stage tibiotalar arthritis. A key deciding point between the two is anticipated functional outcome postoperatively, especially in regards to sports related activities. However, there is a paucity of data available to help advise patients in their decision making. While TAR provides a theoretical benefit of improved functionality, the outcomes of several European studies have shown mixed results. These studies are limited by small sample size, obsolete TAR implants not used in the United States, and nonspecific outcome measures. The purpose of this study was to compare postoperative sports activity levels following modern TAR and AA in a U.S. population, which may benefit surgical decision making and guide patient expectations. Methods: We conducted a retrospective comparative study that consisted of patients who underwent a TAR (N=62) or AA (N=51) between 2009-2015. The mean age of the arthrodesis group was 57.7 years ± 12.12 (28.84-85.26). There were 27 male participants and 24 female participants. The TAR group had 31 male and 31 female participants with a mean age of 64.9 years ± 8.57 (45-79.6). Exclusion criteria included paralysis, rheumatoid arthritis, revision surgery, incomplete pre- and post-operative scores, and follow up less than 2 years. General health and foot-ankle function were assessed using the SF-12 Health Survey and the revised Foot Function Index (FFI-R) preoperatively and at final follow-up. In addition, activity levels were assessed using a Return to Activities Following Surgery questionnaire that was administered at final follow up. This form included a Visual Analog Scale for Pain, satisfaction questions, and a list of 25 activities. Patients were asked to record their current level of activity, ability to participate pre- and post-surgery, and whether their desired level was met. All three measurements tools were compared between both treatment groups. Results: The SF-12 physical score both groups significantly increased postoperatively from 33.18 ± 10.37 to 43 ± 10.32 for AA’s and from 32.88 ± 9.44 to 45.81 ± 12.94 (p < 0.001) for TAR’s. The FFI scores showed a significant increase in both groups (p < 0.001). In the AA group, 88% of patients returned to work and would repeat the surgery, compared to 92% of patients in the TAR group. In terms of satisfaction and pain, the TAR group was more satisfied (1.78 vs. 1.44) and had less postoperative pain (1.32 vs. 2.56 p < 0.05). The AA group reported a significant increase in six activities including: golf (p < 0.05), weight lifting, and walking (p<0.001), while the TAR group reported significant increase in 15 activities, including hiking, tennis, and yoga (p<0.001). Conclusion: Our study revealed a significant increase in general physical function, foot function, and activity level in both groups. The TAR group was able to perform a wider range of activity and sports compared to the AA group. Overall, TAR patients were significantly more satisfied with their procedure compared to AA patients.

Trends in the Use of Total Ankle Replacement and Ankle Arthrodesis in the United States Medicare Population

2013 ◽  
Vol 35 (3) ◽  
pp. 207-215 ◽  
Author(s):  
Andrew J. Pugely ◽  
Xin Lu ◽  
Annunziato Amendola ◽  
John J. Callaghan ◽  
Christopher T. Martin ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Ankle Arthrodesis ◽  
Total Ankle Replacement ◽  
Medicare Population ◽  
Ankle Replacement

scholarly journals Bent or broken: analysis of set screw fracture in the TFNa implant

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Matthew Klima
Keyword(s):  
The United States ◽  
Rotational Instability ◽  
Level Of Evidence ◽  
Screw Insertion ◽  
Lag Screw ◽  
Femoral Shortening ◽  
United States Food ◽  
User Facility ◽  
Helical Blade ◽  
Proximal Screw

Abstract Objectives To evaluate set screw fracture in the Trochanteric Femoral Nail Advanced implant (TFNa, Synthes, West Chester, PA) and to identify additional mechanisms of set screw failure in the TFNa. Materials and methods Patients who had experienced failure after open reduction and internal fixation (ORIF) with the TFNa were identified. TFNa implants were explanted and inspected following revision surgery. Medical device reports (MDRs) and manufacturer’s inspection reports describing similar failures for the TFNa in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database were also reviewed. Results Four set screw fractures that occurred at a level II trauma center were observed. Sixty-seven reported failures were identified in the MAUDE database for review. Twenty-eight failed implants were returned to the manufacturer for inspection with a published inspection report available for analysis. Set screw fractures can occur in the TFNa when the set screw is deployed prematurely into the proximal screw aperture prior to blade/screw insertion. The set screw can also bend and deform if it is advanced against a helical blade/lag screw that is not fully seated into position, thereby potentially compromising its function. Conclusion The TFNa set screw allows for potential fracture during implant insertion leading to uncontrolled collapse, early excessive proximal femoral shortening, and rotational instability of the helical blade/lag screw. Similar failures in the TFNa can be prevented by having the surgeon inspect the proximal screw aperture after attachment of the proximal aiming aim to ensure the set screw has not been deployed prematurely. Level of evidence Therapeutic Level III.

scholarly journals Economic Analysis and Surgical Outcomes of Outpatient Versus Inpatient Total Ankle Replacement Surgery

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0001
Author(s):  
Craig C. Akoh ◽  
Jie Chen ◽  
Rishin J. Kadakia ◽  
Amanda N. Fletcher ◽  
Mark E. Easley ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Patient Reported Outcomes ◽  
The United States ◽  
Small Sample ◽  
Total Ankle Replacement ◽  
Total Direct Cost ◽  
Complication Rates ◽  
Short Stay ◽  
Ankle Replacement ◽  
Patient Reported

Category: Ankle Arthritis; Ankle; Other Introduction/Purpose: The utilization of total ankle replacement (TAR) for end-stage ankle osteoarthritis continues to increase in the United States. From 2011-2012, 47.5% of all TAR were covered by Medicare insurance, which represents a large insurance market share for inpatient ankle surgeries. However, there is a growing trend in orthopedics toward performing outpatient surgery. There have been studies that demonstrate the cost benefits and safety of outpatient TAR surgery. However, previous cost studies involve a single implant, small sample size, and lack clinical outcomes. Thus, we aim to compare the costs and clinical outcomes associated with TAR in the outpatient versus inpatient settings. Methods: We performed a retrospective study on 178 consecutive patients undergoing primary inpatient versus short-stay designation TAR during the 2016 and 2017 fiscal years. Patient demographics, concomitant procedures, perioperative complications, patient reported outcomes, and perioperative costs were collected. Results: The mean age of our cohort was 62.5 yo. The implant types were: Infinity (39.3%), Salto (38.2%), INBONE (15.2%), Vantage (7.3%), and STAR (3.4%). 47.8% of patients were covered under managed care and 42.1% under Medicare. There were no significant differences in medical comorbidities (p > 0.05) or concomitant surgeries (p=0.4574) between inpatient and outpatient groups. There was no difference in complications between inpatient and outpatient groups (p= 0.9652). Inpatients had a greater improvement in their SMFA function score compared to outpatients (p=0.0442). Both inpatient and outpatient cohorts significantly improved in all other reported patient reported outcomes at final follow-up (<0.0001) without a difference between groups (p >0.05). The total direct cost was higher for the inpatient group ($15,340.1) versus outpatient group ($13,002.6) (p<0.0001). Conclusion: While inpatient designation TAR were more comorbid, short-stay designation TAR were associated with a 15.5% reduction in perioperative costs, comparable complication rates, and similar final postoperative patient reported outcome scores compared to inpatient TAR. [Table: see text]

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