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 Adverse Events Related to Polyvinyl Alcohol Hydrogel Hemiarthroplasty of 1st Metatarsal: An Analysis of Reports to the United States Food and Drug Administration

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0006
Author(s):  
Sreenivasulu Metikala ◽  
Karim Mahmoud Khamis ◽  
Kathryn O’Connor ◽  
Wen Chao ◽  
Keith L. Wapner ◽  
...  
Keyword(s):  
United States ◽  
Foreign Body ◽  
Adverse Events ◽  
Polyvinyl Alcohol ◽  
Foreign Body Reaction ◽  
Bone Erosion ◽  
The United States ◽  
The Us ◽  
United States Food ◽  
States Food

Category: Midfoot/Forefoot Introduction/Purpose: Polyvinyl Alcohol Hydrogel (PAH) hemiarthroplasty has gained popularity in the operative management of symptomatic hallux rigidus since its introduction to the US in July 2016. Despite encouraging initial results, any implant has the potential for complications that may not become apparent until it is in widespread use. Also, the series of publications supporting the effectiveness of PAH have come from a limited group of institutions and surgeons which creates an opportunity for observational bias. Other complications or unsatisfactory outcomes may be under-reported, such as those experienced in community centers due to the challenges in publishing lower volume work. In order to look at a broader range of potential complications, we reviewed the United States Food and Drug Administration’s (FDA) database and compared with published literature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database of the US Food and Drug Administration (FDA) was retrospectively reviewed between July 2016 and October 2019 using the assigned product code: PNW for the PAH implant. All the reported adverse events, implant-related complications, and secondary procedures were analyzed. Results: A total of 49 events have been reported to this voluntary database over the past 3 years while over 22,000 Cartiva devices have been implanted. Implant subsidence was the most common with 16 reported instances. Fragmentation of the device was observed in nine and four reports were related to infection in which two were deep infections needing antibiotic spacers. Bone erosion managed by grafting was documented in three reports and foreign body reaction was noted in one. Persistent pain and swelling were common presentations. Thirty-five of 49 reported events required additional operative procedures performed at a mean interval of 4.75 months following the index procedure while four more were awaiting further surgery. Conversion to fusion was the most common procedure, featured in 10 reports. Conclusion:: The analysis of the MAUDE database disclosed certain device-related dysfunctions that have been under-reported in the published literature. Also, complications such as fragmentation, bone erosion and foreign body reaction have not been previously described. Awareness of these details will assist in decision-making and quality control. Due to the voluntary nature of reporting, the true incidence of each complication is unknown with the above data representing a baseline. Nonetheless, the MAUDE database serves as an illuminating source of information which would further be strengthened by a more robust and mandatory reporting of device-related complications. [Table: see text][Table: see text]

scholarly journals Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU

2018 ◽  
Vol 6 (2) ◽  
pp. 8-13
Author(s):  
Philip Saddik ◽  
John Pappan
Keyword(s):  
United States ◽  
The United States ◽  
The European Union ◽  
Oral Diseases ◽  
External Appearance ◽  
Regulatory Systems ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Therapeutic Properties

Regulating oral rinses has been and still is a topic of debate and confusion. Oral rinses are products that are mainly used for cleaning, perfuming and changing the appearance of the teeth, which in turn improves the individual’s external appearance. Adding medicinal ingredients to these rinses, it can then be used for the elimination and/or prevention of some oral diseases, an example being gingivitis. The United States Food and Drug Administration placed guidelines which state that mouthwashes with possible therapeutic properties should be registered as drugs rather than cosmetics. Meanwhile, on a different continent, Germany along with the other members of the European Union decided not to categorize mouthwashes as drugs, but rather as cosmetics, using its sole purpose of cleaning and beautifying the teeth as the excuse. The following research will thoroughly differentiate between the diverse regulatory systems forced upon mouthwashes across the two countries—the United States and Germany.

scholarly journals Analysis of Crowdsourced Metformin Tablets from Individuals Reveals Widespread Contamination with N-Nitrosodimethylamine (NDMA) in the United States

2020 ◽  
Author(s):  
Qian Wu ◽  
Evgenia Kvitko ◽  
Amber Jessop ◽  
Shannon Williams ◽  
Ryan C. Costantino ◽  
...  
Keyword(s):  
United States ◽  
High Resolution Mass Spectrometry ◽  
Daily Intake ◽  
The United States ◽  
Product Recalls ◽  
Acceptable Daily Intake ◽  
Drug Products ◽  
Post Market ◽  
United States Food ◽  
States Food

AbstractRecent reports of metformin drug products contaminated with unacceptable levels of the probable human carcinogen N-Nitrosodimethylamine (NDMA) prompted a national sampling of post-market metformin drug products. To most broadly sample the market and minimize supply chain bias, metformin medication samples were crowdsourced directly from individuals across many states in the United States. 128 samples were received, and liquid chromatography-high resolution mass spectrometry tests for a panel of nitrosamines revealed significant levels of NDMA that trend with labeling company. 42% of all medication samples contained detectable levels of NDMA and, when scaled to maximum daily tablet dose, 36% of all medication samples contained NDMA levels exceeding the FDA daily acceptable intake limit. The highest NDMA detection from the tested samples was 1565 ng per tablet, which, when commonly taken four times a day, is 65 times the United States Food and Drug Administration (FDA) acceptable daily intake limit. Results underscore the need for immediate product recalls of tainted medications and an overall investigation of metformin manufacturing practices.

Program planning with Tobit analysis—the United States food stamp case

1980 ◽  
Vol 14 (2) ◽  
pp. 91-95
Author(s):  
J.E. Epperson ◽  
M.R. Holmes ◽  
C.L. Huang ◽  
W.K. Scearce
Keyword(s):  
United States ◽  
Program Planning ◽  
The United States ◽  
Food Stamp ◽  
Tobit Analysis ◽  
United States Food ◽  
States Food

Potassium binders

ESC CardioMed ◽  
2018 ◽  
pp. 218-221
Author(s):  
Keld P. Kjeldsen ◽  
Juan Tamargo ◽  
Thomas A. Schmidt
Keyword(s):  
United States ◽  
Clinical Pharmacology ◽  
Gastrointestinal Tract ◽  
The United States ◽  
European Medicines Agency ◽  
Sodium Polystyrene Sulfonate ◽  
United States Food ◽  
States Food ◽  
Potassium Binders ◽  
Sodium Zirconium Cyclosilicate

Potassium binders are used for the treatment of and prophylaxis against hyperkalaemia. Already in 1958, the United States Food and Drug Administration (FDA) approved sodium polystyrene sulfonate, a potassium binder exchanging sodium for potassium in the gastrointestinal tract. In 2015, the FDA approved a new potassium binder, patiromer sorbitex calcium (Veltassa®), exchanging calcium for potassium, and in 2017, it was approved by the European Medicines Agency (EMA). Furthermore, in 2018, the FDA and the EMA approved another new potassium binder, sodium zirconium cyclosilicate (Lokelma®), exchanging sodium for potassium. The clinical pharmacology aspects of potassium binders are reviewed in this chapter.

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