BIRMINGHAM HIP RESURFACING (BHR) 74121138Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010502766), received between Apr 10, 2019 and May 27, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PLAINTIFF UNDERWENT A BHR PRIMARY SURGERY ON (B)(6) 2008. IN 2023 THE PATIENT TESTED FOR ELEVATED COBALT CHROMIUM LEVELS, AND MEDICAL IMAGES SHOWED A CYSTIC LUCENCY AT THE FEMORAL HEAD NECK. ALSO, THE PATIENT EXPERIENCED NEUROLOGIC ISSUES AND THEREFORE WAS DIAGNOSED WITH METALLOSIS. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SURGERY AND WAS CONVERTED INTO A THA USING DEPUY ORTHOPAEDICS DEVICES AND KEEPING THE BHR ACETABULAR COMPONENT. PATIENT TOLERATED THE PROCEDURE WELL. ON THE SAME DAY OF REVISION, POST-OP EXAMINATION FOUND THEY WERE HEMODYNAMICALLY STABLE, WITH SOME CONTROLLED PAIN OF ANTERIOR HIP, AND X-RAYS SHOWED APPROPRIATE SEATING OF HARDWARE.

  Patient problems: Metal Related Pathology; Nerve Damage

  MAUDE report 19400957 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A PRIMARY BIRMINGHAM RIGHT HIP RESURFACING (BHR) ON (B)(6) 2005. THE PATIENT PRESENTED PERSISTENT PAIN IN HER RIGHT HIP, ESPECIALLY DURING STANDING AND WALKING. BLOOD TESTS WERE PERFORMED AND INDICATED NO SINGS NEITHER AN INFECTION NOR PSOAS TENDONITIS. X-RAYS AND CT WERE TAKEN TO THE PATIENT AND REVEALED A LUCENCY PRESENT AROUND THE PEG OF THE FEMORAL COMPONENT OF THE RIGHT HIP. THIS COMPLICATION WAS SOLVED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2008. DURING THE PROCEDURE, IT WAS NOTICED THAT THE ACETABULUM WAS IN GOOD CONDITION AND THERE WAS SOME MOVEMENT ON THE FEMORAL PEG. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Inadequate Osseointegration; Radiolucent Lines

  MAUDE report 17684957 ↗
• InjuryMay 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON LITERATURE REVIEW "METAL-ON-METAL HIP RESURFACING ARTHROPLASTY PROVIDES EXCELLENT LONG-TERM SURVIVORSHIP AND FUNCTION IN PATIENTS WITH A GOOD SIZED FEMORAL HEAD." 1 PATIENT SUFFERED FEMORAL COMPONENT LOOSENING 13.83 YEARS AFTER A BHR AND REQUIRED A REVISION SURGERY. THERE'S NO MORE INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14323142 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "METAL-ON-METAL HIP RESURFACING ARTHROPLASTY PROVIDES EXCELLENT LONG-TERM SURVIVORSHIP AND FUNCTION IN PATIENTS WITH A GOOD SIZED FEMORAL HEAD.", 1 PATIENT SUFFERED FEMORAL NECK FRACTURE 2.33 YEARS AFTER A BHR AND REQUIRED A REVISION SURGERY. THERE'S NO MORE INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 14311950 ↗
• InjuryJan 13, 2021Mechanical Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT HIP RESURFACING (BHR) ON, THE PATIENT DEVELOPED CHRONIC HIP PAIN, LIMITED ABILITY TO AMBULATE. UPON CLINICAL EVALUATION, SHE WAS FOUND TO PRESENT ELEVATED COBALT AND CHROME LEVELS IN BLOOD AND RIGHT HIP SYNOVIAL TISSUE INFLAMMATION. IN ADDITION, AND MRI REVEALED BHR SYSTEM MECHANICAL FAILURE. THESE COMPLICATIONS WERE TREATED BY CONDUCTING A CONVERSION TO TOTAL HIP ARTHROPLASTY ON (B)(6) 2020, IN WHICH THE FEMORAL RESURFACING HEAD WAS EXPLANTED AND THE ACETABULAR CUP WAS RETAINED. A BIRMINGHAM DUAL MOBILITY XLPE INSERT WAS PLACED ALONG WITH A POLARSTEM FEMORAL STEM AND AN OXINIUM FEMORAL HEAD. PATIENT¿S OUTCOME IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; High metal ion levels; Implant Pain; Metal Related Pathology; Pain; Synovitis

  MAUDE report 11167385 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT RECEIVED A BIRMINGHAM HIP RESURFACING AND NOW NEEDS THE FEMORAL COMPONENT REVISED DUE TO FRACTURE DUE TO A FALL IN (B)(6) 2018. A CUSTOM DUAL MOBILITY INSERT IS PLANNED TO TREAT THE PATIENT. THEREFORE AT PRESENT, NO REVISION OPERATION HAS OCCURRED BUT WILL BE PERFORMED.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 8499207 ↗

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-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-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-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-0019-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant component.
• Z-0030-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. 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-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component.
• Z-0029-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0031-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. 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.

…and 14 more.