BIRMINGHAM HIP RESURFACING (BHR) 74120164Recalls & reported problems
Smith & Nephew, Inc. · ACETABULAR CUP HAP 64MM WITH IMPACTOR · Class 3
All models of BIRMINGHAM HIP RESURFACING (BHR) (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010502636), received between Feb 5, 2019 and Apr 26, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).
29 other recalls cover devices cleared under the same FDA submission (P040033); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loss of Osseointegration1
Patient problems
- Debris, Bone Shedding1
- Inadequate Osseointegration1
- No Code Available1
- Pain1
- Patient Problem/Medical Problem1
- Test Result1
- Toxicity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT ON LITERATURE REVIEW "BIRMINGHAM HIP RESURFACING FOR OSTEOARTHRITIS, A CANADIAN RETROSPECTIVE COHORT STUDY WITH A MINIMUM 10-YEAR FOLLOW-UP", AFTER A BHR RESURFACING SURGERY PERFORMED DUE TO OSTEOARTHRITIS, PATIENT EXPERIENCED ACETABULAR CUP LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY 56 MONTHS AFTER IMPLANTATION. A CONVERSION FROM BHR RESURFACING TO A BHR THA WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Inadequate Osseointegration
MAUDE report 16820253 ↗InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY FROM THE RIGHT HIP WAS PERFORMED PAIN, METALLOSIS TRUNNIONOSIS, PSEUDOTUMOR AND EXTENSIVE BONE LOSS.
Patient problems: Debris, Bone Shedding; No Code Available; Pain; Patient Problem/Medical Problem; Test Result; Toxicity
MAUDE report 8304063 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P040033. One submission often covers many models, so check the product and lot details in each record.
- Z-2242-2021 · Jul 14, 2021 · Terminatedsmith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
- Z-2267-2018 · May 11, 2018 · TerminatedBirmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
- Z-2268-2018 · May 11, 2018 · TerminatedBirmingham 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) Siz
- Z-2745-2015 · Jun 3, 2015 · TerminatedSmith & 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 M
- Z-2747-2015 · Jun 3, 2015 · TerminatedSmith & 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) Pro
- Z-2746-2015 · Jun 3, 2015 · TerminatedSmith & 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), 74
- Z-0022-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component.
- Z-0024-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component.
- Z-0025-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component.
- Z-0019-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant component.
- Z-0016-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
- Z-0028-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
- Z-0020-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component.
- Z-0032-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component.
- Z-0026-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component.
…and 14 more.
Other Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing devices
- BIRMINGHAM HIP RESURFACING (BHR) 74120156Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing3 deaths145 reports
- BIRMINGHAM HIP RESURFACING (BHR) 74120152Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing139 reports
- BIRMINGHAM HIP RESURFACING (BHR) 74121146Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing91 reports
- BIRMINGHAM HIP RESURFACING (BHR) 74121150Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing1 death86 reports
- BIRMINGHAM HIP RESURFACING (BHR) 74122154Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing75 reports
- BIRMINGHAM HIP RESURFACING (BHR) 74120154Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing2 deaths70 reports
- BIRMINGHAM HIP RESURFACING (BHR) 74122158Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing69 reports
- BIRMINGHAM HIP RESURFACING (BHR) 74120160Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing62 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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