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BIRMINGHAM HIP RESURFACING (BHR) 74122150Recalls & reported problems

Smith & Nephew, Inc. · ACETABULAR CUP HAP SIZE 44/50 · 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 hip implant that caps the ball of the hip rather than replacing the whole joint. The 43 reports mostly describe pain and metal-related problems years after surgery — high cobalt and chromium levels, metallosis (metal-stained tissue), fluid and bone loss around the implant, and implant loosening or failure, with several patients needing revision surgery. No deaths were reported, but all 43 reports involve injuries. 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
43
Deaths reported
0
Injuries reported
43
Recalls naming it
0

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 03596010552273), received between Apr 6, 2017 and Jun 9, 2026 — classified as 43 injuries.

The most frequently reported specific device problem is “Biocompatibility” (20 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: 2 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 3 reportsJul 2024: 2 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: 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

  • Biocompatibility20
  • Adverse Event Without Identified Device or Use Problem17
  • Appropriate Device Problem Term/Code Not Available9
  • Insufficient Device Problem Information4
  • Patient Device Interaction Problem3
  • Loss of Osseointegration2
  • Migration2
  • Compatibility Problem1

Patient problems

  • Metal Related Pathology19
  • Pain13
  • Injury9
  • No Code Available7
  • Failure of Implant6
  • Toxicity6
  • High metal ion levels4
  • Test Result4

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 9, 2026Biocompatibility

    IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT BHR-THA SURGERY ON (B)(6) 2010 DUE TO BILATERAL OSTEOARTHRITIS, SHE EXPERIENCED PAIN AND THIS WAS INTERFERING WITH HER DAILY ACTIVITIES. A DECREASED RANGE OF MOTION WAS NOTICED AS WELL. IT WAS DETERMINED THAT THE METAL-ON-METAL ARTICULATION WITH ASR CUP IMPLANTED HAD FAILED. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH SURGEON CONVERTED TO TOTAL HIP REPLACEMENT ARTHROPLASTY. THERE WERE METAL DEBRIS PRESENT ON THE INSIDE OF THE FEMORAL HEAD AND THE TRUNNION. THERE WAS APPROXIMATELY 30% ABDUCTOR DAMAGE AS A DIRECT RESULT OF METALLOSIS DAMAGE TO THE ABDUCTOR MUSCLES. THE STEM WAS STABLE AND WELL FIXED, SO IT WAS NOT REVISED. THE SURGEON NOTICED METALLOSIS STAINED TISSUE THROUGHOUT THE HIP JOINT, MOST PRONOUNCED ANTERIOR HIP CAPSULE AND SURROUNDING THE PROXIMAL FEMORAL STEM. IT WAS ALSO EXTENSIVE ALONG THE POSTERIOR CAPSULE AND SOFT TISSUES OF PROXIMAL FEMUR; AND ALONG THE BACKSIDE OF THE ACETABULAR IMPLANT. THE CUP WAS EASILY REMOVED, THE HEAD WAS NOTICED TO HAVE METAL DEBRIS INSIDE THE TRUNNION AREA, THIS WAS REMOVED AND REPLACED. THE STEM TRUNNION ALSO HAD METAL DEBRIS BUT WA

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

    MAUDE report 25439193 ↗
  • InjuryJul 2, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER UNDERGOING A LEFT BHR-THA ON (B)(6) 2009, THE PATIENT WAS DIAGNOSED WITH ELEVATED METAL ION LEVELS ON OR ABOUT (B)(6) 2024. THEREFORE, THEY ARE SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2024. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: High metal ion levels

    MAUDE report 19655033 ↗
  • InjuryJul 1, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT AFTER A PRIMARY LEFT BHR SURGERY WAS PERFORMED ON (B)(6)2011, THE PATIENT SUFFERED FROM DEEP GROIN PAIN, ELEVATED METAL ION LEVELS, LIMITED RANGE OF MOTION; CATCHING AND POPPING IN HIP; RECENT ONSET OF EMESIS DAILY; WEIGHT LOSS; LEUKOCYTOSIS; IMPAIRED KIDNEY AND LIVER FUNCTION; ENLARGED AND THICKENED PANCREAS; FATIGUE; SHORT TERM MEMORY LOSS. THE PATIENT WAS TREATED WITH PT, ANTI-INFLAMMATORY AND CORTISONE INJECTIONS. LEFT HIP OF BILATERAL PATIENT WITH REVISION RECOMMENDED BUT NOT SCHEDULED / PERFORMED.

    Patient problems: Arthralgia; High metal ion levels

    MAUDE report 19652052 ↗
  • InjuryJun 10, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT HIP RESURFACING (BHR) ON (B)(6) 2009 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED PAIN, ELEVATED METAL ION LEVELS AND LOCALIZED METALLOSIS. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2015, DURING WHICH BOTH RESURFACING COMPONENTS WERE EXPLANTED. DURING THIS PROCEDURE, SOME FOCAL GRAYISH-APPEARING TISSUE WAS OBSERVED ANTEROMEDIALLY WITHIN THE CAPSULE, WHICH WAS THOUGH TO REPRESENT MELANOSIS. CONVERSION TO A COMPETITOR¿S THA SYSTEM (STRYKER) WAS SUCCESSFULLY PERFORMED. A STERILE DRESSING WAS APPLIED, AND THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION.

    Patient problems: Metal Related Pathology

    MAUDE report 19501115 ↗
  • InjuryJun 6, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A RIGHT BHR WAS PERFORMED ON 05-FEB-2008, THE PATIENT DEVELOPED ELEVATED COBALT LEVELS. THEREFORE A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2017, DURING WHICH THE BHR SYSTEM WAS CONVERTED INTO A THA USING COMPETITOR AND S+N IMPLANTS. NO OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: High metal ion levels

    MAUDE report 19477354 ↗
  • InjuryJun 4, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A LEFT BHR WAS PERFORMED ON (B)(6) 2008, THE PATIENT DEVELOPED ELEVATED COBALT LEVELS. THEREFORE A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2017, DURING WHICH THE BHR SYSTEM WAS CONVERTED INTO A THA USING COMPETITOR AND S+N IMPLANTS. THE PATIENT TOLERATED THE PROCEDURE WELL A RETURNED TO RECOVERY ROOM IN STABLE CONDITION.

    Patient problems: High metal ion levels

    MAUDE report 19459808 ↗
  • InjuryMay 24, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER UNDERGOING LEFT BHR ON (B)(6) 2010 DUE TO ADVANCED ARTHRITIS, THE PATIENT DEVELOPED HIP PAIN AND METALLOSIS. IN ADDITION TO ELEVATED CHROMIUM AND COBALT SERUM LEVELS FOUND IN BLOOD, MRIS SHOWED A PERIPHERAL SCLEROSIS ALONG ACETABULUM, CONSISTENT WITH POST-ARTHROPLASTY OSTEOLYSIS AND PARTICLE DISEASE. THESE COMPLICATIONS WERE TREATED WITH A REVISION SURGERY ON (B)(6) 2024, DURING WHICH COPIOUS METAL STAINED SYNOVIUM AND LARGE 3X3 OSTEOLYTIC, DARK GREY/BLACK STAINED LESIONS WERE FOUND IN THE ACETABULUM. BOTH RESURFACING COMPONENTS WERE REMOVED AND CONVERSION TO A COMPETITOR'S THA WAS PERFORMED (DJO GLOBAL).

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

    MAUDE report 19397622 ↗
  • InjuryMay 22, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT BHR ON (B)(6) 2010 DUE TO ADVANCED ARTHRITIS, THE PATIENT PRESENTED METALLOSIS AND PERIACETABULAR OSTEOLYSIS. IN ADDITION TO ELEVATED CHROMIUM AND COBALT SERUM LEVELS FOUND IN BLOOD, MRIS REVEALED A CORTICAL IRREGULARITY OF THE RIGHT INFERIOR PUBIC RAMI, CONSISTENT WITH A PATHOLOGIC FRACTURE, AND A PSEUDOTUMOR FORMATION. THESE COMPLICATIONS WERE TREATED WITH A REVISION SURGERY ON (B)(6) 2023, DURING WHICH ACETABULAR SEVERE INFERIOR POSTERIOR BONE LOSS AND METAL-STAINED HIP CAPSULE WERE FOUND. BOTH RESURFACING COMPONENTS WERE REMOVED AND CONVERSION TO A COMPETITOR'S THA WAS PERFORMED (DJO GLOBAL).

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

    MAUDE report 19377322 ↗
  • InjuryJan 19, 2024Biocompatibility; Migration; Biocompatibility; Migration

    IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED METALLOSIS AND IMPLANT MOBILIZATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENTS STATUS IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 18543474 ↗
  • InjuryJan 18, 2024Biocompatibility; Migration; Biocompatibility; Migration

    IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED METALLOSIS AND IMPLANT MOBILIZATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENTS STATUS IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 18536700 ↗
  • InjurySep 5, 2023Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR THA PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED METALLOSIS AND THE DEVELOPMENT OF A PSEUDOTUMOR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014, IN WHERE THE ACETABULAR CUP AND FEMORAL HEAD WERE EXPLANTED, BONE GRAFTING WAS PERFORMED TO ACETABULUM, AND THEN THE IMPLANTS WERE REPLACED FOR A TRABECULAR METAL ZIMMER CUP, A LIPPED LINER, A SYNERGY STEM AND AN OXINIUM HEAD. ALSO, THE THE PSEUDOTUMOR WAS EXCISED, ALONG WITH EXCESSIVE SYNOVIUM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 17684964 ↗
  • InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A BILATERAL BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN IN THE RIGHT HIP AND UNSPECIFIED SYSTEMIC SYMPTOMS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR CUP WAS EXPLANTED AND REPLACED WITH A THR SYSTEM. INTRAOPERATIVELY, A MILD DARK STAINING OF THE SYNOVIUM WAS NOTED AROUND THE METAL-ON-METAL ARTICULATION. THE PATIENT¿S OUTCOME IS UNKNOWN.

    Patient problems: Arthralgia; Insufficient Information; Metal Related Pathology; Pain

    MAUDE report 15080408 ↗
  • InjuryJun 30, 2022Biocompatibility; Biocompatibility

    BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN, ELEVATED COBALT ION LEVELS IN BLOOD AND PSEUDOTUMOR FORMATION. A MARS MR SCAN SHOWED A LOCAL ADVERSE TISSUE REACTION IN THE RIGHT HIP. A REVISION ARTHROPLASTY WAS CONDUCTED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR ACETABULAR CUP AND RESURFACING HEAD WERE EXPLANTED AND REPLACED WITH A COMPETITOR¿S THR SYSTEM. THE PATIENT¿S OUTCOME IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 14872584 ↗
  • InjuryJun 28, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN AND WAS DIAGNOSED WITH METALLOSIS IN HER LEFT HIP. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR RESURFACING HEAD WAS EXPLANTED AND A COMPETITOR¿S DUAL MOBILITY LINER WITH A REPLACED FEMORAL COMPONENT WERE CHOSEN AS NEW COMPONENTS. THE PATIENT¿S OUTCOME IS NOT KNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 14845257 ↗
  • InjuryMay 21, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A LEFT BHR WAS PERFORMED ON (B)(6) 2012 DUE TO SEVERE OSTEOARTHRITIS, THE PATIENT EXPERIENCED ELEVATED LEVELS OF COBALT AND CHROMIUM IN BLOOD. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2020, IN WHICH THE BHR FEM HEAD WAS EXPLANTED AND THE BHR ACETABULAR CUP WAS RETAINED. THE NEXT DAY, THE PATIENT FELL AND EXPERIENCED A PERIPROSTHETIC FRACTURE, FOR WHICH A SECOND REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020. THE IMPLANTS PLACED IN THE FIRST AND SECOND REVISION SURGERY ARE FROM ANOTHER MANUFACTURER. THE BHR ACETABULAR CUP HAS NOT BEEN EXPLANTED. THE PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 14465964 ↗
  • InjuryApr 13, 2022Biocompatibility; Biocompatibility

    US LEGAL IT WAS REPORTED THAT, AFTER LEFT BIRMINGHAM HIP RESURFACING SURGERY WAS PERFORMED ON (B)(6) 2014 DUE TO PAIN, STIFFNESS, CATCHING AND DECREASED ACTIVITY CAPABILITIES, THE PATIENT EXPERIENCED PAIN, SIGNIFICANT FLUID COLLECTION AROUND HER POSTERIOR HIP CAPSULES, AS WELL AS SIGNIFICANTLY ELEVATED CHROMIUM AND COBALT IONS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2020, IN WHICH A DUSKY GRAY-APPEARING INFLAMED SYNOVIUM WAS NOTICED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Metal Related Pathology; Pain; Synovitis

    MAUDE report 14102000 ↗
  • InjuryJan 12, 2022Biocompatibility; Biocompatibility

    US LEGAL. IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A MEDICALLY INDICATED REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2020 DUE TO PAIN IN THE JOINT AND METALLOSIS. THE OUTCOME OF THE PATIENT IS UNKNOWN. THE LEFT HIP BHR PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009.

    Patient problems: Metal Related Pathology

    MAUDE report 13242275 ↗
  • InjuryDec 24, 2021Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER RIGHT BHR IN (B)(6) 2010, THE PLAINTIFF HAS SUFFERED OF SEVERE PAIN, METALLOSIS, ADVERSE LOCAL TISSUE REACTION, BROWN SYNOVIUM CONSISTENT WITH PSEUDOTUMOR AND LOOSENING OF THE FEMORAL COMPONENT. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2019. THE FEMORAL HEAD WAS EXPLANTED AND, AS THE CUP WAS WELL FIXED IN PLACE, IT WAS LEFT INSIDE THE PATIENT. THE PATIENT WAS BROUGHT TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION.

    Patient problems: Metal Related Pathology

    MAUDE report 13084413 ↗
  • InjuryJul 8, 2021Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF'S RIGHT HIP ON (B)(6) 2013, THE PLAINTIFF EXPERIENCED ELEVATED COBALT AND CHROMIUM LEVELS (22.8 PPB) AND A LARGE PSEUDOTUMOR FORMATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. THE FEMORAL HEAD WAS EXPLANTED, AND THE CUP WAS LEFT IN PLACE. THE PLAINTIFF'S OUTCOME IS UNKNOWN.

    Patient problems: Metal Related Pathology; Solid Tumor

    MAUDE report 12135274 ↗
  • InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO HIGH METAL IONS ON BLOOD. THE BHR WAS ORIGINALLY IMPLANTED ON (B)(6) 2013. THE METAL BLOOD LEVELS WERE CO 17.2 AND CR 10.4. CONVERTED TO AN ANTHOLOGY WITH BDMH. PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 11617748 ↗
  • InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A RIGHT HIP REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE CONSISTENT ELEVATED ION LEVELS. THE PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Infiltration into Tissue

    MAUDE report 11357758 ↗
  • InjuryFeb 2, 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 THE PATIENT LEFT HIP ON (B)(6) 2018. THE PATIENT REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN, LIMITED MOBILITY, AND ELEVATED COBALT AND CHROMIUM LEVELS. AMONG THE INTRAOPERATIVE FINDINGS THERE WAS METAL DEBRIS AND ALTR/ALVAL REACTION AS A RESULT OF THE PREMATURE FAILURE OF THE DEVICE, ALONG WITH TRUNNIONOSIS, FLUID AND SOFT TISSUES. THE PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Joint Dislocation; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Osteopenia/ Osteoporosis; Pain

    MAUDE report 11269775 ↗
  • InjuryNov 26, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A LEFT HIP BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2009, THE PATIENT SUSTAINED INCREASED PAIN. RADIOGRAPHS OF HER LEFT HIP CONFIRMED A PERIPROSTHETIC FEMORAL NECK FRACTURE AROUND HER RESURFACING HEAD COMPONENT. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 TO TREAT THIS COMPLICATION. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS EXCISED AND REPLACED WITH A COMPETITOR¿S FEMORAL SYSTEM. INTRAOPERATIVELY, THERE WAS OSTEOLYSIS NOTED AROUND THE FEMORAL NECK THAT REMAINED ON THE HIP RESURFACING COMPONENT. UPON ENTERING THE CAPSULE, A GRAYISH APPEARING SYNOVIAL TISSUE WITH DEBRIS WITHIN THE FLUID WAS ENCOUNTERED. AN ABNORMAL SOFT TISSUE/INFLAMMATORY TISSUE CONSISTENT WITH ADVERSE REACTION TO METAL WEAR DEBRIS WAS ALSO NOTED. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Patient problems: Fall; Hip Fracture; Metal Related Pathology; Osteolysis; Pain

    MAUDE report 10909202 ↗
  • InjurySep 21, 2020Loss of Osseointegration; Biocompatibility; Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Biocompatibility; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 ON THE PATIENT LEFT HIP DUE TO MECHANICAL LOOSENING OF THE PROSTHESIS, SUBSTANTIAL PAIN AND SUFFERING. DURING THE REVISION SURGERY, METAL STAINING WAS NOTICED IN THE SYNOVIUM SURROUNDING THE FEMORAL NECK AND THE RIM OF THE ACETABULUM. THE CUP WAS NOTICED TO BE GROSSLY LOOSE. BOTH RESURFACING METALLIC COMPONENTS WERE EXPLANTED AND REPLACED WITH THA SYSTEM. THE PRIMARY LEFT HIP SURGERY WAS PERFORMED ON (B)(6) 2009.

    Patient problems: Injury; Metal Related Pathology; Pain

    MAUDE report 10563475 ↗
  • InjuryJul 24, 2020Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENTS RIGHT HIP DUE TO PAIN, ELEVATED HIGH ION METALS AND LOOSENING OF THE IMPLANT. THE PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Injury; Pain

    MAUDE report 10319353 ↗

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

…and 14 more.

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