BIRMINGHAM HIP RESURFACING (BHR) 74120166Recalls & reported problems
Smith & Nephew, Inc. · ACETABULAR CUP HAP 66MM 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010502643), received between May 10, 2023 and May 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
Patient problems
- Infiltration into Tissue1
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2023Biocompatibility; Biocompatibility
IT WAS REPORTED THAT, AFTER A RIGHT THA SURGERY WAS PERFORMED ON (B)(6) 2008 DUE TO OSTEOARTHRITIS, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO METALLOSIS, PSEUDOTUMOR AND OSTEOLYSIS. DURING THE PROCEDURE, A LARGE AMOUNT OF YELLOW BLACKISH FLUID SYNOVIAL FLUID AND PSEUDOTUMOR FORMATION WAS FOUND INSIDE THE SURFACE OF THE CAPSULE. THERE WAS SIGNIFICANT BONE LOSS AROUND THE PROXIMAL FEMUR AND WHILE TRYING TO EXPOSE THE FEMORAL COMPONENT, THE GREATER TROCHES BROKE AND BONE GRAFT WAS USED TO TREAT THIS MATTER. ADDITIONALLY, DURING THE PROCEDURE THERE WAS CONCERN OF BLOOD LOSS FROM THE ACETRABULUM AND TWO UNITS OF PACKED RED BLOOD CELLS WERE PROVIDED TO THE PATIENT. THE HEMI HEAD, MODULAR SLEEVE AND ACETABULAR CUP WERE EXPLANTED AND REPLACE WITH SMITH AND NEPHEW DEVICES. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE.
Patient problems: Infiltration into Tissue; Metal Related Pathology
MAUDE report 16903317 ↗
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-0030-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component.
- Z-0029-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component.
- Z-0027-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. 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-0020-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. 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-0023-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component.
- Z-0025-2008 · Jul 12, 2007 · TerminatedSmith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. 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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