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BIRMINGHAM HIP RESURFACING (BHR) 74121154Recalls & reported problems

Smith & Nephew, Inc. · RESURFACING FEMORAL HEAD 54MM · Class 3 · Implant

All models of BIRMINGHAM HIP RESURFACING (BHR) (47)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Smith & Nephew Birmingham Hip Resurfacing femoral head is a metal hip resurfacing implant. Reports mostly describe pain, elevated metal levels, loosening or tissue and bone damage that mention revision surgery years after implantation. There are 42 reports that name its identifier, all involving injury, with no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
42
Deaths reported
0
Injuries reported
42
Recalls naming it
0

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 03596010502803), received between Jul 13, 2017 and Jun 4, 2026 — classified as 42 injuries.

The most frequently reported specific device problem is “Biocompatibility” (18 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 3 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem19
  • Biocompatibility18
  • Appropriate Device Problem Term/Code Not Available3
  • Loosening of Implant Not Related to Bone-Ingrowth3
  • Device Dislodged or Dislocated2
  • Insufficient Device Problem Information2
  • Break1
  • Collapse1

Patient problems

  • Metal Related Pathology17
  • Pain14
  • Failure of Implant9
  • High metal ion levels6
  • Arthralgia4
  • Necrosis4
  • Hip Fracture3
  • Implant Pain3

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 4, 2026Biocompatibility

    IT WAS REPORTED THAT, AFTER UNDERWENT A BHR-LEFT HIP ON (B)(6) 2004 & A BHR-RIGHT HIP (B)(6) 2006 DUE TO UNKNOWN REASONS. THERE WAS AN ATTEMPTED TO DO A LEFT HIP REPLACEMENT SURGERY ON (B)(6) 2016, HOWEVER, A RAPID DROP IN BLOOD PRESSURE, LED TO ABANDONMENT OF THE PROCEDURE AT THAT DATE. THEY NOTED HIS RECORDED PROBNP LEVEL WAS 235 NG/L, TO WHICH ELEVATED LEVELS WERE A KNOWN ASSOCIATION WITH COBALT-INDUCED CARDIOMYOPATHY. THE PROCEDURE WAS LATER PERFORMED ON (B)(6) 2016. PATIENT CURRENT HEALTH CONDITION IS UNKNOWN.

    Patient problems: High metal ion levels; Low Blood Pressure/ Hypotension

    MAUDE report 25396061 ↗
  • InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A BHR SURGERY PERFORMED 18 YEARS AGO, PATIENT DEVELOPED AN INFECTION WHICH LED TO NECROSIS OF THE FEMORAL NECK AND SUBSEQUENT FRACTURE OF THE FEMORAL NECK. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025 IN WHICH A RESURFACING FEMORAL HEAD 54MM WAS EXPLANTED AND REPLACED WITH AN ANTIBIOTIC SPACER. PATIENT IS RECOVERING FROM INFECTION WITH THE ANTIBIOTIC SPACER.

    Patient problems: Bone Fracture(s); Medical device site infection; Necrosis

    MAUDE report 21935346 ↗
  • InjuryMar 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT ON LITERATURE REVIEW "BIRMINGHAM HIP RESURFACING AT 25 YEARS", ONE (1) PATIENT AFTER A RIGHT BHR HIP RESURFACING PROCEDURE, DEVELOPED ASEPTIC LOOSENING OF THE FEMORAL COMPONENT ELEVEN YEARS AND SIX MONTHS POSTOPERATIVE. PATIENT REQUIRED REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Aseptic loosening

    MAUDE report 21646579 ↗
  • InjuryMar 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT ON LITERATURE REVIEW "BIRMINGHAM HIP RESURFACING AT 25 YEARS", ONE (1) PATIENT AFTER A LEFT BHR HIP RESURFACING PROCEDURE, DEVELOPED ASEPTIC LOOSENING OF THE FEMORAL COMPONENT TEN YEARS POSTOPERATIVE. PATIENT REQUIRED REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Aseptic loosening

    MAUDE report 21646552 ↗
  • InjuryMar 19, 2025Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT ON LITERATURE REVIEW "BIRMINGHAM HIP RESURFACING AT 25 YEARS", ONE (1) PATIENT AFTER 14 YEARS OF A RIGHT BHR HIP RESURFACING PROCEDURE, DEVELOPED RIGHT GROIN PAIN, WITH ELEVATED METAL IONS (CR 339 NMOL/L, CO 161 NMOL/L) AND A SMALL, < 4 CM FLUID COLLECTION ON ULTRASOUND SCAN COMMUNICATING WITH THE PSOAS TENDON. FEMORAL HEAD AVASCULAR NECROSIS (AVN) WAS DETECTED ON RADIOGRAPHS WITH PROGRESSIVE COLLAPSE OF COMPONENT. PATIENT REQUIRED REVISION SURGERY TO AN UNCEMENTED PROSTHESIS WITH METAL-ON-POLYETHYLENE BEARING. FOLLOWING REVISION SURGERY, AT ONE YEAR, METAL ION LEVELS RETURNED TO NORMAL (CR 28 NMOL/L, CO 15 NMOL/L) AND OHS SCORE WAS 31. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Arthralgia; High metal ion levels; Metal Related Pathology; Necrosis

    MAUDE report 21646122 ↗
  • InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER A THR SURGERY, THE PATIENT EXPERIENCED A COLLAPSED HEAD 17 YEARS POST-OPERATION. THE INSPECTION OF BONE IN THE FEMORAL HEAD FOUND EXTENSIVE AVASCULAR NECROSIS (AVN), QUITE POSSIBLY DUE TO LONG-TERM STEROID USE. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED.

    Patient problems: Necrosis

    MAUDE report 19357947 ↗
  • InjuryAug 31, 2023Biocompatibility; Noise, Audible; Biocompatibility; Noise, Audible

    IT WAS REPORTED THAT A RESURFACING RIGHT HIP PROCEDURE WAS PERFORMED ON (B)(6) 2008 USING A BHR SYSTEM DUE TO OSTEOARTHRITIS. AFTER THE PROCEDURE, THE PATIENT STARTED TO GET PAIN WITH CLICKING AND CLUNKING NOISES AND ELEVATED COBALT CHROME LEVELS. THESE ADVERSE EVENTS WERE TREATED VIA REVISION SURGERY ON (B)(6) 2012. THE REVISION OF THE RIGHT TOTAL HIP ARTHROPLASTY WAS COMPLETED USING COMPETITOR IMPLANTS. NO FURTHER COMPLICATION HAS BEEN REPORTED.

    Patient problems: High metal ion levels

    MAUDE report 17664215 ↗
  • InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP RESURFACING (BHR) ON (B)(6) 2008 DUE TO DEGENERATIVE JOINT DISEASE, THE PATIENT EXPERIENCED LEFT GREATER TROCHANTERIC BURSITIS. THIS ADVERSE EVENT WAS TREATED ON (B)(6) 2017 BY ADMINISTERING A 40 MG/ML METHYLPREDNISOLONE ACETATE JOINT INJECTION (DEPO-MEDROL®).

    Patient problems: Bursitis

    MAUDE report 17114028 ↗
  • InjuryJun 8, 2023Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT HIP RESURFACING (BHR) SURGERY DUE TO OSTEOARTHRITIS ON (B)(6) 2008, THE PATIENT EXPERIENCED METAL-ON-METAL ARTICULATION WITH ELEVATED SERUM METAL ION LEVELS. THIS EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE FEMORAL COMPONENT WAS EXPLANTED, AND A COMPETITOR¿S THA DUAL MOBILITY CONSTRUCT (STRYKER) WAS PLACED FOR THE INDWELLING SOCKET. DURING THIS PROCEDURE, A DISCREPANCY BETWEEN THE LEG LENGTHS WAS OBSERVED. INTRAOPERATIVELY, BOTH RESURFACING COMPONENTS WERE CONFIRMED TO BE WELL-FIXED, AND UPON FEMORAL HEAD REMOVAL, THE METAL COMPONENTS WERE NORMAL IN APPEARANCE WITHOUT EVIDENCE OF WEAR OR DAMAGE. THERE WAS NO MACROSCOPIC EVIDENCE OF METAL DEBRIS, AND THE SURROUNDING SOFT TISSUE ENVELOPE WAS HEALTHY IN APPEARANCE. SURGERY WAS SUCCESSFULLY COMPLETED, AND THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT IN STABLE CONDITION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: High metal ion levels; Unequal Limb Length

    MAUDE report 17092071 ↗
  • InjuryMay 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    LEGAL IT WAS REPORTED THAT AFTER A LEFT BHR SURGERY PERFORMED ON (B)(6) 2007, DUE TO OSTEOARTHRITIS, THE PLAINTIFF STARTED TO EXPERIENCE INCREASING PAIN AND X-RAYS SHOWED LOOSENING OF THE FEMORAL SIDE WITH IMPINGEMENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 WHERE THE RESURFACING FEMORAL HEAD WAS REMOVED, AND THE CUP WAS KEPT. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO POST-ANESTHESIA CARE IN GOOD CONDITION WITHOUT COMPLICATIONS.

    Patient problems: Implant Pain

    MAUDE report 16957619 ↗
  • InjuryMay 14, 2023Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

    IT WAS REPORTED THAT, AFTER RIGHT HIP RESURFACING (BHR) WAS PERFORMED ON (B)(6) 2011 DUE TO OSTEOARTHRITIS AND HIP PAIN SUBSEQUENT TO A WORK INJURY, THE PATIENT EXPERIENCED PAIN ALONG WITH IMPLANT CORROSION. THIS COMPLICATION WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022, IN WHICH BOTH RESURFACING COMPONENTS WERE EXPLANTED, AND A COMPETITOR¿S THA SYSTEM (STRYKER) WAS PLACED IN EXCHANGE. DURING THIS PROCEDURE, SYNOVIAL FLUID SAMPLES WERE COLLECTED; HOWEVER, TEST RESULTS ARE NOT AVAILABLE AT THIS TIME. THE PATIENT RETURNED TO THE PACL IN STABLE CONDITION.

    Patient problems: Failure of Implant; Implant Pain; Insufficient Information

    MAUDE report 16928309 ↗
  • InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISE A 20-YEAR-OLD BHR RESURFACING DUE TO PAIN. NO BLACKENING OF TISSUES WAS NOTICED. IT WAS CUT THE NECK AND REMOVED THE BHR 54MM RESURFACING HEAD. IT IS UNKNOWN THE CURRENT HEALTH STATE OF THE PATIENT.

    Patient problems: Pain

    MAUDE report 15266687 ↗
  • InjuryJul 26, 2022Loss of Osseointegration; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER UNDERGOING A RIGHT HIP BHR RESURFACING SURGERY ON (B)(6) 2010 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A SUSTAINED PERIPROSTHETIC HIP FRACTURE AT THE FEMORAL NECK OF A BHR. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022. AFTER THIS SURGERY, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

    Patient problems: Hip Fracture; Inadequate Osseointegration; Metal Related Pathology

    MAUDE report 15105854 ↗
  • InjuryMay 31, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2021 SECONDARY TO SQUEAKING NOISE, METALLOSIS, ELEVATED METAL ION LEVELS AND PAIN. DURING THE REVISION, THE CUP WAS PRESERVED, AND THE FEMORAL HEAD WAS EXPLANTED. THE SYSTEM WAS CONVERTED TO A THA. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PRIMARY RIGHT HIP BHR PROCEDURE WAS PERFORMED ON (B)(6) 2010.

    Patient problems: Metal Related Pathology

    MAUDE report 14549351 ↗
  • InjuryMay 31, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT THE PLAINTIFF EXHIBITED ELEVATED METAL ION LEVELS IN BLOOD AFTER A LEFT HIP BHR PRIMARY SURGERY (ABOUT 20 MCG/L). NO REVISION SURGERY OR ANY OTHER MEDICAL INTERVENTION HAS BEEN INDICATED FOR THE PATIENT´S LEFT HIP, HOWEVER, THE PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY DUE TO METALLOSIS ON (B)(6) 2021 (COVERED UNDER (B)(4)). THIS CASE WAS CREATED BECAUSE WE CAN NOT RULE OUT THE CONTRIBUTION OF THE LEFT HIP BHR SYSTEM IN THE ALLEGED ELEVATION OF METAL ION LEVELS. THE PRIMARY LEFT HIP BHR SURGERY WAS PERFORMED ON (B)(6) 2010.

    Patient problems: Metal Related Pathology

    MAUDE report 14549256 ↗
  • InjuryMay 25, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED METALLOSIS, PAIN, INSTABILITY, AND THREE DISLOCATIONS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY AND OPEN BIOPSY ON (B)(6) 2022. AFTER THIS PROCEDURE, THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION. IN ADDITION, THE PATIENT HAD PREVIOUSLY UNDERWENT A PRIMARY RIGHT BHR SURGERY ON (B)(6) 2007, HOWEVER, NO COMPLICATIONS HAVE BEEN REPORTED REGARDING THE RIGHT HIP.

    Patient problems: Joint Dislocation; Metal Related Pathology; Pain

    MAUDE report 14493759 ↗
  • InjuryApr 20, 2022Biocompatibility; Biocompatibility

    US LEGAL: BILATERAL PATIENT. IT IS REPORTED THAT, AFTER A LEFT BHR ON (B)(6) 2012, PLAINTIFF HAS EXPERIENCED EXTREME HIP PAIN, LOCAL ADVERSE TISSUE REACTION AND METALLOSIS. PLAINTIFF IS SCHEDULED FOR MEDICALLY INDICATED REVISION SURGERY ON THE LEFT BHR IMPLANTS ON (B)(6) 2022. THE PATIENT'S CONDITION IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 14161447 ↗
  • InjuryApr 7, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2006, THE PLAINTIFF EXPERIENCED METAL-ON-METAL REACTION WITH PSEUDOTUMOR FORMATION AND ELEVATED LEVELS OF COBALT AND CHROMIUM IONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, BOTH THE BHR ACETABULAR CUP AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A FULL THR SYSTEM. INTRAOPERATIVELY, THE FEMORAL NECK AND REMAINING HEAD SEGMENTS WERE NOTICED TO BE EXTREMELY OSTEOLYTIC. THE PLAINTIFF WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PLAINTIFF¿S OUTCOME IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 14048790 ↗
  • InjuryMar 31, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT AFTER A BHR SURGERY ON (B)(6) 2007, THE PATIENT PRESENTED HIGH CO AND CR LEVELS. THE ADVERSE EVENT WAS TREATED VIA REVISION SURGERY ON (B)(6) 2022 AND THE RESURFACING FEMORAL HEAD 54MM WAS EXPLANTED. PATIENT CURRENT STATUS IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 13958249 ↗
  • 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 13865423 ↗
  • 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 13865156 ↗
  • 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 12964470 ↗
  • InjuryNov 30, 2021Break; Break

    IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2021, THE PATIENT FELL AND EXPERIENCED THE BREAKAGE OF AN ACETABULAR CUP HAP SIZE 52/60 AND A RESURFACING FEMORAL HEAD 54MM. THIS INCIDENT WAS SOLVED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

    Patient problems: Fall

    MAUDE report 12893124 ↗
  • InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A BHR SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED IMPLANT FAILURE AND UNKNOWN SYMPTOMS. TO TREAT THIS ADVERSE EVENT, A REVISION SURGERY IS NEEDED AND WILL BE SCHEDULED TO EXPLANT A RESURFACING FEMORAL HEAD 54MM. THE EXPLANTED DEVICE WILL BE REPLACED WITH A BHR DUAL MOBILITY IMPLANT. CURRENT PATIENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Failure of Implant

    MAUDE report 11891192 ↗
  • InjuryMay 21, 2021Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF LEFT HIP ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN AND ELEVATED METAL ION LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS REVISION SURGERY, THE SURGEON NOTICED THAT THE SYNOVIAL TISSUE WAS SOMEWHAT METALLIC STAINED, AND THERE WAS A LITTLE REACTIVE CYST BEHIND THE CUP. THE PATIENT'S OUTCOME IS UNKNOWN.

    Patient problems: Metal Related Pathology; Pain

    MAUDE report 11861462 ↗

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-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-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-0024-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. 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-0029-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. 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-0020-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. 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-0033-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. 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.

…and 14 more.

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