BIRMINGHAM HIP RESURFACING (BHR) 74120146Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010502544), received between May 30, 2017 and Feb 27, 2024 — classified as 9 injuries.

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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY RIGHT BHR WAS PERFORMED ON (B)(6) 2007, LATER THE PLAINTIFF STARTED TO EXPERIENCE PAIN THAT INTERFERED WITH THEIR DAILY ACTIVITIES, AND RADIOGRAPHIC EVIDENCE OF FEMORAL NECK LUCENCY WAS FOUND. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH BOTH BHR COMPONENTS WERE EXCHANGED FOR COMPETITOR DEVICES. EXCESSIVE SCAR TISSUE WAS NOTICED AROUND THE CUP AND THE CUP WAS IN A LATERAL POSITION. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Deformity/ Disfigurement; Inadequate Osseointegration; Osteolysis; Pain; Scar Tissue

  MAUDE report 18791908 ↗
• InjurySep 5, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY (THA) REVISION SURGERY ON THE RIGHT HIP ON (B)(6) 2008. THE PATIENT EXPERIENCED THE PRESENCE OF A PSEUDOTUMOR DEHISCENCE OF THE DEEP TISSUES FROM THE HIP TO THE VERTICAL CUP. THIS COMPLICATION WAS TREATED BY CONDUCTING A SECOND REVISION SURGERY ON (B)(6) 2010. DURING THE PROCEDURE, IT WAS ENCOUNTERED A PSEUDOCYST FILLED WITH FLUID AND METAL. TROCHANTER APPEARED TO BE DEFICIENT, AND THE MUSCLES WERE ATROPHIC AND SCARRED. ALSO, THE ACETABULAR CUP WAS SOMEWHAT OPEN. THE ACETABULAR CUP, MODULAR HEAD AND MODULAR SLEEVE WERE EXPLANTED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 17687756 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY, IT WAS NECESSARY TO PERFORM A REVISION SURGERY IN WHICH AN ACETLR CUP HAP 46MM W/ IMPTR WAS EXPLANTED; HOWEVER, IT IS UNKNOWN THE REASON THAT LED TO THIS SURGERY. THE CURRENT HEALTH STATUS OF THE PATIENT IS ALSO UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12741798 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR THA WAS PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED INFECTION AND METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. ALL THE COMPONENTS WERE EXPLANTED. IT IS UNKNOWN IF THE PATIENT RECEIVED ANY MEDICATION TO TREAT THE INFECTION. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Unspecified Infection

  MAUDE report 12012574 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; 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 11167339 ↗
• InjuryMar 12, 2019Corroded; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. METALLOSIS WITH PSEUDOCYSTS AND OSSEOUS DEFECTS IN THE ACETABULUM AND INCREASED SERUM CONCENTRATIONS OF COBALT AND CHROMIUM. DEVICES IMPLANTED IN 2009.

  Patient problems: Cyst(s); Injury; No Code Available; Patient Problem/Medical Problem; Toxicity

  MAUDE report 8412111 ↗
• InjuryJan 25, 2019Protective Measures Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS.

  Patient problems: No Code Available

  MAUDE report 8277114 ↗
• InjuryJun 20, 2017Appropriate 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 RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO INCREASING PAIN AND SWELLING WITH SEVERE METAL-METAL REACTION AROUND THE HIP JOINT.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 6652847 ↗
• InjuryMay 30, 2017Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO PAIN, DISLOCATION AND SWELLING WITH METAL REACTION AROUND THE HIP JOINT.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 6597280 ↗

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-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-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. 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-0020-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. 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-0016-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. 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-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.

…and 14 more.