Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA adverse event reports and recall history for prosthesis, hip, semi-constrained, metal/metal, resurfacing (product code NXT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 6,882
- Deaths
- 18
- Injuries
- 6,573
- Malfunctions
- 118
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2018-05-21TerminatedProcess control
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
- 2018-05-21TerminatedProcess control
Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
- 2015-09-10TerminatedDevice Design
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
- 2015-09-10TerminatedDevice Design
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
- 2015-09-10TerminatedDevice Design
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
- TerminatedComponent change control
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
The nail head may become detached during surgery.
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