How much does a medical and healthcare products regulatory agency medical device alert for metal-on-metal hip arthroplasty patients really cost?

Background: Many worldwide regulatory authorities recommend regular surveillance of metal-on-metal hip arthroplasty patients given high failure rates. However, concerns have been raised about whether such regular surveillance, which includes asymptomatic patients, is evidence-based and cost-effective. We determined: (1) the cost of implementing the 2015 MHRA surveillance in “at-risk” Birmingham Hip Resurfacing (BHR) patients; and (2) how many asymptomatic hips with adverse reactions to metal debris (ARMD) would have been missed without patient recall. Methods: All BHR patients eligible for the 2015 MHRA recall (all females, and males with head sizes ⩽46 mm, regardless of symptoms) at one centre were invited for review (hips = 707; patients = 593). All patients were investigated (Oxford Hip Score, radiographs, blood metal ions, and targeted cross-sectional imaging) and managed accordingly. Surveillance costs were calculated using finance department data. Results: The surveillance cost £105,921.79 (range £147.76–£257.50/patient). Radiographs (£39,598) and nurse practitioner time/assistance (£23,618) accounted for 60% of overall costs. 31 hips had ARMD on imaging (12 revised; 19 under surveillance). All revisions were symptomatic. 7 hips with ARMD under surveillance were asymptomatic and remain under regular review. The number needed to treat to avoid missing one asymptomatic ARMD case was 101 patients, representing a cost of £18,041 to avoid one asymptomatic case. Conclusions: Implementing MHRA surveillance for “at-risk” BHR patients was extremely costly. The risk of asymptomatic ARMD was low with the BHR (1%), suggesting recommended follow-up in asymptomatic patients is not cost efficient. This raises concerns about the increasingly intensive surveillance recommended in the 2017 MHRA guidance for metal-on-metal hip patients.

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The Effectiveness of Blood Metal Ions in Identifying Patients with Unilateral Birmingham Hip Resurfacing and Corail-Pinnacle Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris

The Journal of Bone and Joint Surgery (American) ◽

10.2106/jbjs.15.00340 ◽

2016 ◽

Vol 98 (8) ◽

pp. 617-626 ◽

Cited By ~ 23

Author(s):

Gulraj S. Matharu ◽

Fiona Berryman ◽

Lesley Brash ◽

Paul B. Pynsent ◽

Ronan B.C. Treacy ◽

...

Keyword(s):

At Risk ◽

Metal Ions ◽

Adverse Reactions ◽

Hip Resurfacing ◽

Hip Implants ◽

Metal Debris ◽

Birmingham Hip Resurfacing ◽

Metal On Metal

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Limited need for screening of metal-on-metal hip resurfacing patients beyond 10 years of follow-up

Hip International ◽

10.1177/1120700020917939 ◽

2020 ◽

pp. 112070002091793

Author(s):

Walter van der Weegen ◽

Henk Hoekstra ◽

Koen Brakel ◽

Thea Sijbesma

Keyword(s):

Hip Arthroplasty ◽

Metal Ion ◽

Hip Resurfacing ◽

Implant Survival ◽

Long Term Outcomes ◽

Metal Debris ◽

Metal On Metal ◽

Further Development

Background: National and international guidelines lack consistency on how to screen metal-on-metal (MoM) hip arthroplasty patients for adverse reactions to metal debris (ARMD). Long-term outcomes of MoM hip arthroplasty are scarce, hindering further development of such guidelines. We present the clinical, radiological and ARMD status of 158 cases of hip resurfacing with >10 years follow-up. Methods: A prospective analysis of a cohort of 298 consecutive hip resurfacing procedures was performed at a single institution. All patients underwent MARS-MRI scanning for pseudotumour screening at least once, regardless of symptoms. Implant survival and reasons for revision were analysed for all patients. Clinical, radiological and MARS-MRI results were analysed for 158 unrevised procedures with >10 years follow-up. Results: The implant survival was 85.9% at 14.5 years (95% CI, 81.9–90.6) with revision for all causes as endpoint and 92.3% with MoM disease-related revisions excluded (95% CI, 88.2–95.0). Of the 158 cases with >10 years follow-up, 1 had elevated metal ion levels, 29 had a stable C1 pseudotumour and 6 a stable C2 pseudotumour. All pseudotumours were observed within 3 years after initiating our intensified ARMD screening (2011), with no new pseudotumours observed after that period. Conclusions: We suggest that follow-up of MoM hip resurfacing patients beyond 10 years after surgery can be done with large intervals (i.e. every 5 years), and only earlier if a patient becomes symptomatic.

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Dislocation of a McMinn-Like Prosthesis with Distinctive Metallosis and Fracture of the Os Ilium

Case Reports in Orthopedics ◽

10.1155/2021/6151679 ◽

2021 ◽

Vol 2021 ◽

pp. 1-6

Author(s):

Peter Caspar Bünemann ◽

Stefan Luck ◽

Malte Ohlmeier ◽

Thorsten Gehrke ◽

Tobias Malte Ballhause

Keyword(s):

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Bone Cyst ◽

Treatment Method ◽

Hip Resurfacing ◽

Metal Debris ◽

Total Hip ◽

Metal On Metal ◽

The 1960S ◽

A Minor

Osteoarthritis of the hip joint (coxarthrosis) is the most common hip disease in adults. Since the 1960s, total hip arthroplasty (THA) has made great progress and is nowadays one of the most frequently used procedures in orthopedic surgery. Different bearing concepts exist in various implant designs. A metal-on-metal bearing can create metal debris and lead to metallosis. We present a unique case of a 78-year old woman, who received hip resurfacing with a McMinn-like prosthesis 15 years ago. Over the cause of time, metallosis developed and created a bone cyst in the Os ilium, and osteolysis led to a dislocation of the femoral implant. A minor stumble fall led to a fracture of the Os ilium. We present our treatment method with implantation of a cemented THA and refill of the bone cyst with bone from allogene femoral heads. The surgery led to a reconstruction of the physiological center of rotation in the hip. Consequently, to the inpatient stay, the patient took part in a follow-up treatment with intensive physiotherapy. Taken together, the results after total hip arthroplasty are more superior to other hip surface replacements in terms of longevity and patient satisfaction. Especially, metal-on-metal bearing couples carry a great risk of metallosis, which goes a long with pseudotumors, osteolysis, and the elevated metal ions in the blood. Since this case is unique in the literature, no guidelines are noted for surgical treatment. In our opinion, a periprosthetic fracture of this type should be performed in a hospital using extensive endoprosthetic expertise.

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Small-head metal on metal total hip arthroplasty is associated with a high rate of complication and reoperation at mid-term follow-up

SAGE Open Medicine ◽

10.1177/20503121211014707 ◽

2021 ◽

Vol 9 ◽

pp. 205031212110147

Author(s):

Nobuhiko Sumiyoshi ◽

Kazuhiro Oinuma ◽

Yoko Miura

Keyword(s):

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Adverse Reactions ◽

Small Diameter ◽

High Rate ◽

Metal Debris ◽

Total Hip ◽

Metal On Metal ◽

Small Head

Background: Adverse reactions to metal debris are significant complications after metal-on-metal total hip arthroplasty. Recently, late appearances of adverse reactions to metal debris and subsequent need for reoperations have been reported with small-diameter head metal-on-metal devices. We retrospectively investigated mid-term clinical outcomes of small-head metal-on-metal total hip arthroplasty. Methods: We reviewed 159 hips in 139 patients who had a small-head metal-on-metal total hip arthroplasty (M2a Taper; Biomet, Warsaw, IN) with a minimum 5-year follow-up and documented postoperative complications. Results: Focal osteolysis in either the femur or acetabulum was observed in 12 hips (7.5%, 44 months after surgery on average), with pseudotumor observed in 8 hips (5%, 120 months after surgery on average). Four hips (2.5%) had dislocations (84 months after surgery on average) and six hips (3.8%, 122 months after surgery on average) underwent reoperation. Conclusion: Small-head metal-on-metal total hip arthroplasty is associated with a high degree of complications at mid-term follow-up period. Considering this, we discourage the use of metal-on-metal total hip arthroplasty regardless of head size.

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