BIRMINGHAM HIP RESURFACING (BHR) 74120162Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010502629), received between Jul 18, 2017 and Oct 15, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Biocompatibility” (6 reports).

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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL LEFT HIP REPLACEMENT SURGERY PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A PERI-PROSTHETIC ACETABULAR FRACTURE. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025 IN WHICH ONE (1) ACETLR CUP HAP 62MM W/ IMPTR AND ONE (1) MODULAR HEAD 54MM {} -4 (SHORT) WERE EXPLANTED. A COMPETITOR REVISION CUP AND AN S+N FEMORAL HEAD WERE PLACED. ONE (1) SYN POR PLUS HA SO STEM SZ 18 WAS RETAINED IN-SITU. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Periprosthetic fracture

  MAUDE report 23289612 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT HIP REVISION ON (B)(6) 2023, THE PATIENT PRESENTED CONTINUED NONHEALING SURGICAL INCISION SITE WITH PUS, WHICH REQUIRED IRRIGATION AND DEBRIDEMENT SURGERY ON (B)(6) 2023 WITH REVISION CLOSURE OF THE RIGHT ANTERIOR SURGICAL INCISION SITE. THE PATIENT TOLERATED THE PROCEDURE WELL, WITHOUT COMPLICATIONS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19075395 ↗
• InjuryFeb 21, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, ON (B)(6) 2008 A RIGHT BHR-THR WAS CARRIED OUT DUE TO OSTEONECROSIS OF THE HIP. LATER, THE PLAINTIFF STARTED DEVELOPING PAIN IN THE GROIN AND BUTTOCK REGIONS, AROUND 2012. FURTHERMORE, THEY ALSO DEVELOPED NONSPECIFIC FATIGUE, ISSUES WITH VISION AND GENERAL MALAISE, POSSIBLY ATTRIBUTED TO ELEVATED METAL IONS, THEREFORE A REVISION SURGERY WAS PERFORMED, ON (B)(6) 2014. DURING THE REVISION IT WAS FOUND THAT THE IMPLANTS WERE WELL PLACED; THE ACETABULAR SHELL AND MODULAR HEAD WERE EXCHANGED FOR AN R3 SHELL AND OXINIUM HEAD. THE PATIENT WAS DISCHARGED IN STABLE CONDITION. FURTHER COMPLICATIONS HAVE NOT BEEN REPORTED.

  Patient problems: Discomfort; Fatigue; Unspecified Eye / Vision Problem

  MAUDE report 18753415 ↗
• InjuryApr 26, 2023Biocompatibility; Biocompatibility

  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 PSEUDOTUMOR FORMATION ON 12TH YEAR. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY 160 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: Cyst(s); Metal Related Pathology

  MAUDE report 16820227 ↗
• InjuryJul 26, 2022Biocompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A RIGHT HIP BHR RESURFACING SURGERY ON (B)(6) 2010 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A SUSTAINED PERIPROSTHETIC HIP FRACTURE AT THE FEMORAL NECK OF A BHR. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON 8(B)(6) 2022. AFTER THIS SURGERY, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Hip Fracture

  MAUDE report 15106028 ↗
• InjuryApr 6, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2006, THE PLAINTIFF EXPERIENCED METAL-ON-METAL REACTION WITH PSEUDOTUMOR FORMATION AND ELEVATED LEVELS OF COBALT AND CHROMIUM IONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, BOTH THE BHR ACETABULAR CUP AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A FULL THR SYSTEM. INTRAOPERATIVELY, THE FEMORAL NECK AND REMAINING HEAD SEGMENTS WERE NOTICED TO BE EXTREMELY OSTEOLYTIC. THE PLAINTIFF WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PLAINTIFF¿S OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14023038 ↗
• InjuryMar 9, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 ON THE PATIENT RIGHT HIP DUE TO PAIN AND METALLOSIS. BOTH METALLIC COMPONENTS WERE EXPLANTED DURING THE REVISION SURGERY. THE PRIMARY RIGHT HIP BHR SURGERY WAS PERFORMED ON (B)(6) 2018.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11444176 ↗
• InjuryJan 14, 2020Biocompatibility; Noise, Audible; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED A RIGHT HIP REVISION DUE TO PERSISTENT PAIN, CLICKING SOUND AND ELEVATED TEST RESULTS.

  Patient problems: Metal Related Pathology; Pain; Test Result; Unspecified Immune System Problem

  MAUDE report 9587077 ↗
• InjuryApr 25, 2019Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY FROM THE LEFT HIP WAS PERFORMED TO CERAMIC-ON-POLY POSSIBLY DUE TO OVERSIZED BHR CUP.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8551583 ↗
• InjuryMar 16, 2018Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REVISION OF THE ACETABULAR CUP (ALONG WITH COMPETITOR LINER, HEAD AND STEM) WAS PERFORMED DUE TO INFECTION.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7346203 ↗
• InjuryJul 18, 2017Adverse Event Without Identified Device or Use Problem; Metal Shedding Debris; Adverse Event Without Identified Device or Use Problem

  LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS AND ELEVATED METAL ION LEVELS. BILATERAL PATIENT. RIGHT HIP REVISION REPORTED VIA MDR 3005975929-2017-00162.

  Patient problems: Failure of Implant; Toxicity

  MAUDE report 6720985 ↗

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 · Terminated
  smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
• Z-2267-2018 · May 11, 2018 · Terminated
  Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
• Z-2268-2018 · May 11, 2018 · Terminated
  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) Siz
• Z-2745-2015 · Jun 3, 2015 · Terminated
  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 M
• Z-2746-2015 · Jun 3, 2015 · Terminated
  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), 74
• Z-2747-2015 · Jun 3, 2015 · Terminated
  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) Pro
• Z-0028-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
• Z-0033-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component.
• Z-0021-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component.
• Z-0019-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant component.
• Z-0018-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant component.
• Z-0026-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component.
• Z-0025-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component.
• Z-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component.
• Z-0023-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component.

…and 14 more.