BIRMINGHAM HIP RESURFACING (BHR) 74122160Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010552327), received between Apr 9, 2018 and May 18, 2023 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP BHR CUP REVISION SURGERY ON (B)(6) 2014, THE PATIENT EXPERIENCED CHRONIC PAIN ALONG WITH TOTAL HIP RESURFACING SYSTEM FAILURE. THE PATIENT PRESENTED SIGNIFICANT ANTERIOR ACETABULAR UNDER COVERAGE, AS WELL AS RETROVERSION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A CONVERSION TO TOTAL HIP ARTHROPLASTY ON (B)(6) 2021, IN WHICH BOTH THE ACETABULAR AND FEMORAL COMPONENT WERE EXPLANTED AND REPLACED WITH A COMPETITOR¿S THA SYSTEM (ZIMMER-BIOMET). PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Implant Pain

  MAUDE report 16957610 ↗
• InjuryMay 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A BHR SYSTEM HAD BEEN IMPLANTED ON PLAINTIFF´S RIGHT HIP ON (B)(6) 2012 DUE TO OSTEOARTHRITIS, THE PLAINTIFF EXPERIENCED WEAR OF ARTICULAR BEARING SURFACE THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021 WERE THE ACETABULAR CUP HAP SIZE 52/60 AND FEMORAL HEAD 52MM WERE EXPLANTED AND REPLACED WITH COMPETITOR DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16935732 ↗
• InjuryMay 14, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A BHR SYSTEM HAD BEEN IMPLANTED ON PLAINTIFF´S LEFT HIP ON (B)(6) 2012 DUE TO OSTEOARTHRITIS, THE PLAINTIFF EXPERIENCED WEAR OF ARTICULAR BEARING SURFACE AND PAIN THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021 WERE THE ACETABULAR CUP HAP SIZE 52/60 AND FEMORAL HEAD 52MM WERE EXPLANTED AND REPLACED WITH COMPETITOR DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arthralgia; Insufficient Information; Pain

  MAUDE report 16928310 ↗
• InjuryMar 23, 2022Biocompatibility; Biocompatibility

  *US LEGAL* BILATERAL PATIENT. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2020 DUE TO METALLOSIS, CHRONIC AND INCREASING PAIN, FAILURE OF THE DEVICE. THE PRIMARY RIGHT BHR SURGERY WAS PERFORMED ON (B)(6) 2008. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2019. THE PATIENT CURRENT STATUS IS UNKNOWN.

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

  MAUDE report 13865366 ↗
• InjuryMar 23, 2022Biocompatibility; Biocompatibility

  US LEGAL. BILATERAL PATIENT. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2019 DUE TO METALLOSIS, CHRONIC AND INCREASING PAIN, FAILURE OF THE DEVICE. THE PRIMARY LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2008. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2020. THE PATIENT CURRENT STATUS IS UNKNOWN.

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

  MAUDE report 13865299 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR-THA REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED A SIGNIFICANT ACETABULAR OSTEOLYSIS AND MODEST FEMORAL OSTEOLYSIS IN LIKELY ALVAL LESION (ASEPTIC LYMPHOCYTE-DOMINANT VASCULITIS ASSOCIATED LESION), WITHOUT MOBILIZATION OF THE COMPONENTS. THIS ADVERSE EVENT WAS ADDRESSED BY A SECOND REVISION SURGERY ON (B)(6) 2021 TO EXPLANT THE ACETABULAR CUP HAP SIZE 52/60 AND BHR MODULAR HEAD 52MM. THE SYNERGY SYSTEM WAS RETAINED AND THE SYSTEM WAS CONVERTED TO THR WITH COMPETITOR'S CUP DUAL MOBILITY LINER AND CERAMIC HEAD. IT IS UNKNOWN CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Metal Related Pathology

  MAUDE report 13280318 ↗
• InjuryDec 8, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THR SURGERY, THE OR STAFF GAVE THE SURGEON THE WRONG COLOR CODED COMBO, SO THE SURGEON IMPLANTED AN ACETABULAR CUP HAP SIZE 52/60 WITH A RESURFACING FEMORAL HEAD 54MM. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICES. NO INJURY TO PATIENT REPORTED. THE SALES REP REALIZED ABOUT THIS ISSUE TWO DAYS AFTER THE CASE. FOR NOW IT IS UNKNOWN HOW THIS PROBLEM WILL BE ADDRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964424 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL MDL* IT WAS REPORTED THAT, AFTER A BHR CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED PAIN, LIMITED MOBILITY, EXTENSIVE METALLOSIS AND ADVERSE LOCAL TISSUE REACTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. DURING SURGERY, THE CUP WAS FOUND TO BE IN GOOD POSITION AND WELL FIXED, SO THE SURGEON DECIDED NOT TO EXPLANT IT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 11891196 ↗
• InjuryDec 28, 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 THE PATIENT RIGHT HIP ON (B)(6) 2019. THE REVISION SURGERY WAS PERFORMED DUE TO PAIN, LOOSENING OF RIGHT TOTAL HIP REPLACEMENT, HETEROTOPIC OSSIFICATION, PSEUDOTUMOR FOR METAL ON METAL DEBRIS, CONTRACTURE, COMPRESSION OF SCIATIC NERVE, COMPLEX WOUND. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Extraskeletal ossification; Failure of Implant; Pain

  MAUDE report 11085401 ↗
• InjuryApr 5, 2020Break; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING SURGERY PRIOR INSERTING THE ACETABULAR, IT WAS NOTICED THAT ONE OF THE WIRE LOOPS HAD SNAPPED AND THE COMPONENT HAD LOOSENED IN THE INSERTER MAKING IT DIFFICULT TO SECURELY SEAT THE ACETABULAR COMPONENT IN THE CORRECT POSITION AND ALIGNMENT. DELAY LESS THAN 30 MIN, NO INJURY REPORTED. NO BACKUP DEVICE WAS AVAILABLE.

  Patient problems: Injury; No Code Available

  MAUDE report 9927074 ↗
• InjuryNov 12, 2019Defective Component

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO OSTEOLYTIC DEFECT AROUND THE CUP AND STEM, AND ALSO SUSTAINED A TROCHANTERIC FRACTURE NEAR THE TOP OF THE STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 9309263 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAS PAIN IN BOTH LEFT AND RIGHT HIP BHR RESURFACING AREAS. HE HAS BEEN DIAGNOSED WITH HIGH LEVELS OF COBALT AND CHROMIUM IN BLOOD. THE RIGHT HIP WAS REVISED ON (B)(6) 2020. THE COMPLETE BHR SYSTEM WAS REPLACED BY A THA SYSTEM. THE PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2016.

  Patient problems: Implant Pain; Injury; Pain; Scar Tissue; Synovitis; Test Result; Toxicity

  MAUDE report 8994723 ↗
• InjuryApr 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A LACK OF BONEY IN-GROWTH.

  Patient problems: Injury; No Code Available

  MAUDE report 7406128 ↗

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-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-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-0028-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. 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-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. 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-0021-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. 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-0030-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0032-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. 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.