BIRMINGHAM HIP RESURFACING (BHR) 74123140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010552402), received between Jul 19, 2017 and May 13, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Biocompatibility” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP, THE PATIENT EXPERIENCED ELEVATED METAL ION LEVELS. A THR REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO ADDRESS THIS COMPLICATION. DURING THIS PROCEDURE, THE RESURFACING HEAD WAS EXPLANTED AND REPLACED WITH SMITH & NEPHEW BACK-UP DEVICES. ACETABULAR CUP WAS RETAINED. INTRAOPERATIVELY, AFTER ENTERING THE CAPSULE ABUNDANT STAINING WITH SOME MILDLY DISCOLORED DIRTY DISHWASHER-LIKE JOINT FLUID WAS FOUND. THE PROCEDURE WENT UNEVENTFUL, AND THE PATIENT WAS TRANSFER TO RECOVERY ROOM IN STABLE CONDITION

  Patient problems: Infiltration into Tissue; Metal Related Pathology

  MAUDE report 16926958 ↗
• InjuryMay 23, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2009 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED OSTEOLYSIS, BUTTOCK PAIN AND ELEVATED METAL LEVELS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON 11-MAY-2021, IN WHICH JOINT FLUID, SYNOVIAL HYPERTROPHY AND OSTEOLYSIS OF THE FEMORAL NECK WERE FOUND. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Infiltration into Tissue; Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 14467745 ↗
• InjuryJan 26, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A BHR REVISION SURGERY ON THE LEFT HIP ON (B)(6) 2019 DUE TO PAIN, LIMITED MOBILITY, METAL STAINING OF THE SUB-CUTANEOUS BURSA TISSUE, CLOUDY FLUID IN THE HIP JOINT, COBALT TOXICITY, AND ADVERSE LOCAL TISSUE REACTION. THE PRIMARY LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2008. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Pain

  MAUDE report 13362278 ↗
• InjuryMay 31, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2012 DUE TO OSTEOARTHRITIS OF THE RIGHT HIP, THE PLAINTIFF EXPERIENCED FAILED HIP RESURFACING DEVICE, ADVERSE LOCAL TISSUE REACTION, TISSUE DAMAGE, PERIPROSTHETIC LUCENCY IN THE FEMORAL NECK AND A THIN (1-2 MM) RIM OF REMAINING INTACT CORTEX, METALLOSIS, ELEVATED ION LEVELS, PAIN, INFLAMMATION, AND DIFFICULTY WALKING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. ACETABULAR COMPONENT WAS WELL FIXED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Inflammation; Loss of Range of Motion; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 11910719 ↗
• InjuryMar 25, 2021Adverse 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 2020 ON THE PATIENT'S HIP DUE TO PAIN, REDNESS AND REDUCED MOBILITY.

  Patient problems: Erythema; Loss of Range of Motion; Pain

  MAUDE report 11568171 ↗
• InjuryFeb 24, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO ELEVATED COBALT AND CHROMIUM LEVELS PLUS PAIN ON THE RIGHT SIDE FOLLOWING PRIMARY SURGERY.

  Patient problems: Arthralgia; High metal ion levels; Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 11376071 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BILATERAL PATIENT. PLAINTIFF UNDERWENT MEDICALLY-INDICATED REVISION OF THE BHR LEFT HIP IMPLANTS ON (B)(6) 2009 DUE TO RECURRENT HIP DISLOCATION AND JOINT PAIN. DURING THIS PROCEDURE, THE BHR CUP WAS NOT REVISED AS IT WAS FOUND WELL FIXED, AND THE BHR RESURFACING HEAD WAS EXPLANTED AND EXCHANGED WITH A FULL THR SYSTEM CONSISTING OF A SIZE 11 FEMORAL STEM, A +0MM MODULAR SLEEVE AND A BHR HEMI HEAD SIZE 40MM. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Metal Related Pathology; Pain

  MAUDE report 10907358 ↗
• InjuryJul 19, 2017Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REVISION SURGERY OF THE FEMORAL HEAD ONLY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE 11 DAYS POST-OP. THE ACETABULAR CUP REMAINED IMPLANTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6724122 ↗

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-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.
• Z-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. 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-0020-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. 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-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. 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-0027-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component.

…and 14 more.