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BIRMINGHAM HIP RESURFACING (BHR) 74122154Recalls & reported problems

Smith & Nephew, Inc. · ACETABULAR CUP HAP SIZE 48/54 · Class 3

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 (BHR) is a metal-on-metal implant that caps the femoral head rather than replacing the whole joint. Most of the 75 reports describe patients years after implantation developing hip pain, metal-related tissue damage (metallosis), elevated cobalt and chromium levels, and loosening or fracture of the implant, often leading to revision surgery;74 reports involved injuries and no deaths were reported. 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
75
Deaths reported
0
Injuries reported
74
Recalls naming it
0

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 03596010552297), received between Jun 7, 2017 and Jul 14, 2025 — classified as 74 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (32 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: 6 reportsApr 2024: 0 reportsMay 2024: 4 reportsJun 2024: 1 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: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 2 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: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Biocompatibility32
  • Adverse Event Without Identified Device or Use Problem28
  • Insufficient Device Problem Information9
  • Appropriate Device Problem Term/Code Not Available8
  • Patient Device Interaction Problem6
  • Device Slipped3
  • Metal Shedding Debris3
  • Noise, Audible2

Patient problems

  • Metal Related Pathology32
  • Pain22
  • Failure of Implant13
  • Injury11
  • No Code Available11
  • Toxicity9
  • Infiltration into Tissue8
  • Osteolysis7

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 14, 2025Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT BIRMINGHAM HIP RESURFACING (BHR) TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 DUE TO COXARTHROSIS. THE PATIENT EXPERIENCED LEFT HIP PAIN AND UNDERWENT REVISION SURGERY ON (B)(6) 2018, APPROXIMATELY 7.5 YEARS POST-IMPLANTATION. MICROBIOLOGICAL ANALYSIS OF THE REVISED TISSUE INDICATED CHRONIC INFLAMMATION, FOREIGN BODY REACTION, AND METALLOSIS. THE REVISION WAS COMPLETED USING ALTERNATIVE IMPLANTS. NO OUTCOME DETAILS WERE REPORTED.

    Patient problems: Bursitis; Extraskeletal ossification; Metal Related Pathology

    MAUDE report 22492906 ↗
  • InjuryJul 8, 2025Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT A PATIENT PREVIOUSLY IMPLANTED WITH A RIGHT TOTAL HIP ARTHROPLASTY (THA) ON (B)(6) 2009, UNDERWENT A REVISION SURGERY APPROXIMATELY 10 YEARS POST-IMPLANTATION. A CLINIC NOTE DATED (B)(6) 2019 INDICATED EVIDENCE OF FEMORAL STEM LOOSENING WITH SUSPECTED PSEUDOTUMOR FORMATION RELATED TO METALLIC DEBRIS. THE PATIENT WAS ASYMPTOMATIC AT THAT TIME, WITH NO PAINFUL SYMPTOMS REPORTED. LABORATORY TESTS RECOMMENDED PROSTHETIC REPLACEMENT. A FOLLOW-UP CLINIC NOTE ON (B)(6) 2019 REPORTED CT FINDINGS SUGGESTIVE OF METALLIC INVOLVEMENT AND ELEVATED METAL ION LEVELS (CHROMIUM 13.2 G/L, COBALT 2.4 G/L). THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Joint Laxity; Metal Related Pathology

    MAUDE report 22433953 ↗
  • InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER THE PATIENT UNDERWENT A BHR THA SURGERY IN (B)(6) 2015, THE PATIENT DEVELOPED RIGHT FEMORAL NERVE PALSY. TO TREAT THIS EVENT, THE PATIENT UNDERWENT A NEUROPLASTY OF THE FEMORAL NEVER ON THE (B)(6) 2015. CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Nerve Damage

    MAUDE report 22199803 ↗
  • InjuryMay 14, 2025Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT METAL-ON-METAL BHR ON (B)(6) 2008, DEVELOPED PROGRESSIVE HIP PAIN AND ADVANCED IMAGING WAS PERFORMED. FINDINGS OF OSTEOLYSIS AND SMALL PARTICLE DISEASE ALONG WITH A POSSIBLE CYSTIC MASS TO PELVIS. ALSO, ION LEVELS WERE NOTICED TO BE ELEVATED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH A LARGE JOINT EFFUSION WITH BROWN FLUID WAS FOUND. ALSO, EXTENSIVE METALLOSIS SURROUNDING AND BENEATH FEMORAL/ACETABULAR COMPONENTS WAS NOTICED, RESULTING IN LARGE OSSEOUS DEFECT TO ACETABULUM. THE ACETABULAR COMPONENT AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH COMPETITOR DEVICES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Metal Related Pathology; Osteolysis; Pain

    MAUDE report 22023277 ↗
  • InjuryJun 24, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER THE PLAINTIFF UNDERWENT A THA MOM SURGERY IN (B)(6) 2015, HE EXPERIENCED AN UNSPECIFIED MALFUNCTION. THE PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY IN 2 WEEKS. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Insufficient Information; Metal Related Pathology

    MAUDE report 19600691 ↗
  • InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A LEFT BHR PROCEDURE ON (B)(6) 2013, AND LATER DEVELOPED HIP PAIN. A REVISION WAS PERFORMED ON (B)(6) 2024, IT IS UNKNOWN WHICH DEVICES WERE IMPLANTED. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION, DISCHARGED ON (B)(6) 2024, AND WAS GIVEN SUBSEQUENT PAIN MANAGEMENT CONTROL.

    Patient problems: Implant Pain; Pain

    MAUDE report 19402074 ↗
  • InjuryMay 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT AN UNKNOWN METAL-ON-METAL HIP SURGERY ON AN UNKNOWN DATE. ON (B)(6) 2023 THE PATIENT OBTAINED RESULTS SHOWING HIGH LEVELS OF COBALT AND CHROMIUM IN THE BLOOD. IT IS UNKNOWN IF THIS ADVERSE EVENT WAS TREATED OR IF THERE IS A SCHEDULED REVISION SURGERY TO SOLVE THE PROBLEM OF THE CLAIMANT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

    Patient problems: Arthralgia; High metal ion levels

    MAUDE report 19399041 ↗
  • InjuryMay 24, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A LEFT PRIMARY BHR SURGERY ON (B)(6) 2014. THEY WERE LATER DIAGNOSED WITH A PERIPROSTHETIC FRACTURE OF LEFT FEMORAL NECK, ASEPTIC LOOSENING OF ACETABULAR COMPONENT, ELEVATED SERUM COBALT CHROMIUM LEVELS, METALLOSIS AND EXPERIENCED CHRONIC PAIN AND DYSFUNCTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO EXCHANGE BHR COMPONENTS FOR DEPUY ORTHOPEDICS DEVICES. FURTHER COMPLICATIONS HAVE NOT BEEN REPORTED.

    Patient problems: Bone Fracture(s); Metal Related Pathology

    MAUDE report 19391759 ↗
  • InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, A AFTER A PLAINTIFF UNDERWENT A LEFT PRIMARY BHR ON (B)(6) 2014, ON 26-APR-2014 A MICROBIOLOGY TEST REVEALED THEY HAD A HEAVY STAPHYLOCOCCUS AUREUS WOUND GROWTH. THE INFECTION WAS TREATED WITH MEDICATION. FURTHER INFORMATION REGARDING THIS ADVERSE EVENT WAS NOT REPORTED.

    Patient problems: Post Operative Wound Infection

    MAUDE report 19351978 ↗
  • InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A ANTHOLOGY HO POR PL HA SZ 4, BHR MODULAR HEAD 48MM, MODULAR SLEEVE {} PLUS 0MM 12/14 AND A ACETABULAR CUP HAP SIZE 48/54 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 19006979 ↗
  • InjuryMar 20, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A LEFT PRIMARY BHR ON (B)(6) 2010 AND LATER STARTED EXPERIENCING PAIN. THEREFORE, A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2018, DURING WHICH THE BHR RESURFACING FEMORAL HEAD 48MM AND THE ACETABULAR CUP HAP SIZE 48/54 WERE EXCHANGED FOR COMPETITOR DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Arthralgia; Pain

    MAUDE report 18941181 ↗
  • InjuryMar 18, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A LEFT PRIMARY THA-BHR SURGERY ON (B)(6) 2009, AND THEN STARTED DEVELOPING SYMPTOMS CONSISTENT WITH ALVAL TEN YEARS LATER. THEREFORE, A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2021, DURING WHICH AN INGUINAL SYNOVIAL HERNIATION WAS FOUND AND TREATED, AND THE BHR ACETABULAR AND FEMORAL HEAD COMPONENTS WERE EXCHANGED FOR COMPETITOR DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Hernia; Metal Related Pathology

    MAUDE report 18927244 ↗
  • InjuryMar 18, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A RIGHT PRIMARY BHR ON (B)(6) 2007 AND LATER STARTED EXPERIENCING PAIN. THEREFORE, A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2017, DURING WHICH A MURKY WHITE FLUID NEGATIVE FOR ACUTE INFLAMMATORY CELLS WAS FOUND, AND BOTH BHR COMPONENTS WERE EXCHANGED FOR COMPETITOR DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Arthralgia; Pain; Synovitis

    MAUDE report 18927238 ↗
  • InjuryMar 12, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, THE PLAINTIFF UNDERWENT A RIGHT BHR RESURFACING SURGERY ON (B)(6)2007 BECAUSE THE PATIENT SUFFERED OSTEOARTHRITIS OF THE RIGHT HIP. THE PATIENT HAD ELEVATED METAL ION LEVELS AND SERIAL MRI SCAN SHOWED EXPANSION OF WHAT APPEARED TO BE A PSEUDOTUMOR AROUND THE HIP. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2018. DURING SURGERY, A MILKY WHITE FLUID WAS ENCOUNTERED, IT WAS ANALYZED, AND THE RESULT SHOWED A POSITIVE LOW-GRADE INFECTION. ALSO, WHEN THE FEMORAL COMPONENT WAS EXTRACTED, THE UNDERLYING BONE APPEARED TO HAVE DETERIORATED OR DISAPPEARED. A ACETABULAR CUP HAP SIZE 48/54 AND A BHR RESURFACING FEMORAL HEAD 48MM WERE EXTRACTED AND COMPETITOR DEVICES WERE IMPLANTED WITH A TEMPORARY SPACER DUE TO THE PROBABLE INFECTION. ON (B)(6) 2018, THE SECOND STAGE REVISION WAS PERFORMED WHERE THE SPACERS WERE REMOVED AND COMPETITOR DEVICES WERE IMPLANTED. THERE WERE NO COMPLICATIONS DURING SURGERY AND PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION.

    Patient problems: High metal ion levels; Medical device site infection; Metal Related Pathology; Unspecified Infection

    MAUDE report 18889104 ↗
  • InjuryMar 12, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, A PLAINTIFF WAS DIAGNOSED WITH ELEVATED LEVEL OF CHROMIUM AND COBALT IONS IN PLASMA ON (B)(6) 2023, AFTER UNDERGOING A RIGHT THA-BHR ON (B)(6) 2010. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, DURING WHICH SIGNIFICANT AMOUNT OF SYNOVIAL FLUID AND MILD TRUNNIONOSIS AROUND PROXIMAL PART OF THE STEM WAS FOUND. THE ACETABULAR AND FEMORAL COMPONENTS WERE REPLACED FOR COMPETITOR DEVICES. THE PLAINTIFF WAS TAKEN TO THE PACU IN STABLE CONDITION.

    Patient problems: Extraskeletal ossification; High metal ion levels; Metal Related Pathology

    MAUDE report 18888218 ↗
  • InjuryOct 11, 2023Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, PLAINTIFF UNDERWENT A LEFT BHR SURGERY ON (B)(6) 2011. LATER ON (B)(6) 2023 THE PATIENT WAS DIAGNOSED WITH DANGEROUS LEVELS OF COBALT IN THE BLOODSTREAM. THEREFORE A COMPLETE BHR REVISION WAS PERFORMED ON (B)(6) 2023. PATIENT'S OUTCOME IS UNKNOWN. FURTHER INFORMATION NOT BEEN PROVIDED.

    Patient problems: High metal ion levels; Metal Related Pathology

    MAUDE report 17912229 ↗
  • InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A BHR REVISION SURGERY PERFORMED ON (B)(6) 2019, THE PATIENT PRESENTED REDNESS OF THE DISTAL PORTION OF THE WOUND AS WELL AS TENDERNESS TO PALPATION, DUE TO LOCALIZED CELLULITIS. ANTIBIOTIC PRESCRIBED TO HER PHARMACY. ON (B)(6) 2019. THIS ADVERSE EVENT WAS TREATED WITH PRESCRIBED ANTIBIOTICS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Post Operative Wound Infection

    MAUDE report 17438777 ↗
  • InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER A THR SURGERY WAS PERFORMED USING A SPECTRON MODULAR BIRMINGHAM SYSTEM, A REVISION SURGERY HAD TO BE PERFORMED IN ORDER TO REMOVE THE CUP AND HEAD DEVICES. NO FURTHER INFORMATION AVAILABLE AT THIS MOMENT.

    Patient problems: Insufficient Information

    MAUDE report 17121370 ↗
  • InjuryMay 15, 2023Biocompatibility; Insufficient Device Problem Information; Biocompatibility; Insufficient Device Problem Information

    IT WAS REPORTED THAT, AFTER A BHR SURGERY WAS PERFORMED ON (B)(6) 2016, THE PLAINTIFF EXPERIENCED ELEVATED METAL IONS AND GROIN PAIN. THIS WAS RESOLVED VIA REVISION SURGERY ON (B)(6) 2022, WHERE THE ACETABULAR CUP HAP SIZE 48/54 AND FEMORAL HEAD 48MM WERE REMOVED AND EXCHANGED FOR A COMPETITOR¿S THA. DURING THE SURGERY A CYSTIC STRUCTURE AT THE GREATER TROCHANTER, AS WELL AS BLACK TISSUE WERE REMOVED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Insufficient Information; Metal Related Pathology

    MAUDE report 16935850 ↗
  • InjuryMay 14, 2023Biocompatibility; Insufficient Device Problem Information; Migration; Biocompatibility; Insufficient Device Problem Information; Migration

    IT WAS REPORTED THAT, AFTER A RIGHT BHR RESURFACING PROCEDURE WAS PERFORMED ON THE (B)(6) 2016, THE PATIENT PRESENTED SEVERE PAIN AND X-RAYS SHOWED A MALPOSITION OF THE ACETABULAR COMPONENT AND AN MRI SHOWED SIGNIFICANT INFLAMMATORY SOFT TISSUE DESTRUCTION INVOLVING THE ILIOTIBIAL BAND, GLUTEUS MINIMUS AND HALF OF THE GLUTEUS MEDIUS. THE PATIENT UNDERWENT A REVISION SURGERY ON THE (B)(6) 2023 AND RECEIVED A THA SYSTEM IN EXCHANGE. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Patient problems: Insufficient Information; Local Reaction; Muscle/Tendon Damage

    MAUDE report 16928312 ↗
  • InjuryApr 26, 2023Device Appears to Trigger Rejection; Biocompatibility; Device Appears to Trigger Rejection; Biocompatibility

    IT WAS REPORTED THAT ON LITERATURE REVIEW "BIRMINGHAM HIP RESURFACING FOR OSTEOARTHRITIS ¿ A CANADIAN RETROSPECTIVE COHORT STUDY WITH A MINIMUM 10-YEAR FOLLOW-UP", AFTER A BHR RESURFACING SURGERY PERFORMED DUE TO OSTEOARTHRITIS, PATIENT EXPERIENCED ASEPTIC LYMPHOCYTE-DOMINATED VASCULITIS-ASSOCIATED LESION (ALVAL) AND PSEUDOTUMOUR FORMATION AT 2ND YEAR. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY 110 MONTHS AFTER IMPLANTATION. A CONVERSION FROM BHR RESURFACING TO A BHR THA WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Cyst(s); Metal Related Pathology

    MAUDE report 16820394 ↗
  • InjuryMay 26, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A REVISION SURGERY OF THE RIGHT HIP DUE TO METALLOSIS, ON (B)(6) 2020. DURING PROCEDURE IT WAS FOUND A DISLOCATION OF LARGE MOM PROSTHETIC FEMORAL HEAD POSTERIORLY, SOFT TISSUE DESTRUCTION AND FIBROUS FIXATION OF THE CUP. THE PRIMARY RIGHT BHR THA SURGERY WAS PERFORMED ON (B)(6) 2010. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Joint Dislocation; Metal Related Pathology

    MAUDE report 14519652 ↗
  • InjuryMay 26, 2022Biocompatibility; Biocompatibility

    US LEGAL. BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED PAIN AND ELEVATED ION LEVELS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 14503597 ↗
  • InjuryMay 21, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN AND ELEVATED METAL ION LEVELS INCLUDING 10 TIMES NORMAL COBALT LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETABULAR CUP HAP SIZE 48/54 AND HEMI HEAD 48MM WERE EXPLANTED AND REPLACED WITH AN OXINIUM FEMORAL HEAD AND A BIRMINGHAM DUAL MOBILITY LINER. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

    Patient problems: Arthralgia; Metal Related Pathology

    MAUDE report 14466267 ↗
  • InjuryMay 19, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER PRIMARY LEFT HIP BHR RESURFACING SURGERY WAS PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN AND SUBLUXATION OF THE FEMORAL COMPONENT, FOR WHICH REVISION SURGERY WAS CONDUCTED ON (B)(6) 2012 (COVERED UNDER CASE-(B)(4)). SUBSEQUENTLY, THE PATIENT EXPERIENCED COBALT AND CHROMIUM TOXICITY, AS WELL AS ACETABULAR OSTEOLYSIS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2020. FROM ALL THE COMPONENTS, ONLY THE STEM WAS LEFT IN PLACE. THE SYSTEM WAS REPLACED TO A COMPETITOR´S THA. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Patient problems: Metal Related Pathology; Osteolysis

    MAUDE report 14436754 ↗

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-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-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-0017-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. 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-0022-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. 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-0025-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. 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-0020-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. 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-0033-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component.

…and 14 more.

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