BIRMINGHAM HIP RESURFACING (BHR) 74122156Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010552303), received between Jul 12, 2017 and Feb 20, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PLAINTIFF UNDERWENT A BHR LEFT SURGERY ON (B)(6) 2014, HE EXPERIENCED A SIGNIFICANT PAIN IN THE GROIN AND THIGH, AND ALSO THE SENSATION OF LOOSENESS IN THE COMPONENTS. HE HAD NO SIGNS OF INFECTION, BUT PLAIN FILM X-RAYS SHOWED THE FEMORAL COMPONENT IN VALGUS POSITION THAT WAS MORE VALGUS THAN IDEAL. HOWEVER, THE X-RAY VIEWS SHOWED THAT THE CORTEX NEAR THE TIP OF THE IMPLANT WAS SOMEWHAT THIN. IT WAS FELT THAT DUE TO HIS INCREASE IN PAIN RECENTLY THAT THERE WAS A POSSIBILITY OF FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014, IN WHICH THE SURGEON FOUND THAT THE IMPLANTS WERE WELL FIXED, NO EVIDENCE OF LOOSENING. THE TRACTS FROM THE FEMORAL COMPONENT WERE TRACED WITHIN THE FEMORAL NECK. A BLUNT PROBE WAS PASSED IN THE SAME TRAJECTORY AND IN THE ANTERIOR NECK, WHERE THE BONE WAS QUITE THIN, THERE WAS A SLIGHT DEFECT INDICATING THAT THE CORTICAL BONE WAS BREACHED, WHICH IS PROBABLY THE SOURCE OF THE PATIENT'S PAIN. THE PREVIOUS BHR FEMORAL HEAD AND ACETABULAR CUP WERE EXPLANTED AND IT WAS CONVERTED INTO A THA, A SYNERGY STEM POROUS PLUS HA SZ 14 AND A +4MM FEMORAL HEAD AND NECK WERE IMPLANTED. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. PATIE

  Patient problems: Bone Fracture(s); Deformity/ Disfigurement; Implant Pain; Joint Laxity; Perforation

  MAUDE report 18737875 ↗
• InjuryMay 26, 2022Biocompatibility; Biocompatibility

  US LEGAL: BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER RIGHT BHR SURGERY WAS PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED PAIN AND ELEVATED ION LEVELS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14516528 ↗
• InjuryApr 6, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER RIGHT BHR WAS PERFORMED ON (B)(6) 2020 DUE TO RIGHT HIP ARTHRITIS, THE PATIENT EXPERIENCED PAIN IN GROIN, HIGH ION LEVELS AND SHORT-TERM MEMORY ISSUES. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2020, IN WHICH AN ACETABULAR COMPONENT IN RETROVERSION AND SLIGHT METALLOSIS TO THE TISSUE WERE NOTICED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Memory Loss/Impairment; Metal Related Pathology; Pain

  MAUDE report 14029329 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASONS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10581034 ↗
• InjuryJan 28, 2019Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY OF THE RIGHT HIP WAS PERFORMED DUE TO THE PRESENCE OF A PSEUDOTUMOR.

  Patient problems: Injury; No Code Available

  MAUDE report 8283377 ↗
• InjuryDec 31, 2018Insufficient Device Problem Information

  IT HAS REPORTED THAT DOCTOR FOUND HIGH COBALT LEVELS IN PATIENT'S BLOOD SAMPLE AND DECIDED TO REVISE THE HIP.

  Patient problems: No Information; Toxicity

  MAUDE report 8206955 ↗
• InjuryJul 12, 2017Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO PAIN AND OTHER COMPLICATIONS. SURGEON'S NOTES REPORTEDLY NOTED "IMPENDING FEMORAL NECK FAILURE, SIGNIFICANT PAIN, AND ELEVATED METAL LEVELS" AND "A LOT OF SCLEROSIS AROUND WHERE THE STEM OF THE BHR COMPONENT WAS".

  Patient problems: Failure of Implant; Pain; Toxicity

  MAUDE report 6705133 ↗

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-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-2267-2018 · May 11, 2018 · Terminated
  Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
• 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-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-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-0030-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. 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-0020-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component.
• Z-0016-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
• Z-0027-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component.
• Z-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. 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-0023-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. 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.

…and 14 more.