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BIRMINGHAM HIP RESURFACING (BHR) 74120152Recalls & reported problems

Smith & Nephew, Inc. · ACETABULAR CUP HAP 52MM WITH IMPACTOR · 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 implant has 139 adverse event reports, with no deaths and 139 injuries. Many describe pain, elevated metal ion levels in the blood, bone breakdown around the implant, and revision surgeries. 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
139
Deaths reported
0
Injuries reported
139
Recalls naming it
0

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 03596010502575), received between Apr 12, 2016 and Jul 14, 2025 — classified as 139 injuries.

The most frequently reported specific device problem is “Biocompatibility” (42 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: 1 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 3 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 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: 4 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 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem53
  • Biocompatibility42
  • Appropriate Device Problem Term/Code Not Available35
  • Insufficient Device Problem Information24
  • Patient Device Interaction Problem15
  • Metal Shedding Debris6
  • Patient-Device Incompatibility6
  • Compatibility Problem4

Patient problems

  • Pain64
  • Metal Related Pathology46
  • Failure of Implant41
  • Toxicity27
  • Test Result21
  • Injury20
  • No Code Available13
  • Osteolysis12

Recent adverse event reports

The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEBRIDEMENT OF THE LEFT HIP ON (B)(6) 2012 DUE TO INFECTION, ABSCESS, AND GRANULOMA FORMATION. IMAGING AND CLINICAL FINDINGS WERE CONSISTENT WITH A SUPERINFECTION AND ABSCESS SURROUNDING THE PROSTHETIC COMPONENT. THE INTERVENTION INVOLVED SURGICAL CLEANING AND ANTIBIOTIC TREATMENT. NO PROCEDURAL DELAY OR ADDITIONAL COMPLICATIONS WERE REPORTED AT THE TIME.

    Patient problems: Abscess; Medical device site infection

    MAUDE report 22494470 ↗
  • InjuryJul 14, 2025Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A RIGHT BHR-THA ON (B)(6) 2006. THE PATIENT LATER PRESENTED WITH ELEVATED METAL ION LEVELS (CR 40.9 ¿G/L, CO 69.2 ¿G/L) AND OSTEOLYSIS. IMAGING SHOWED A RETROVERTED FEMORAL ANTEVERSION ANGLE OF -22°, WHICH MAY HAVE CONTRIBUTED TO IMPLANT WEAR. NO REVISION OR SURGICAL INTERVENTION WAS REPORTED FOR THE HIP. THE PATIENT IMPACT WAS LIMITED TO ELEVATED METAL IONS AND OSTEOLYSIS. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: High metal ion levels; Osteolysis

    MAUDE report 22493006 ↗
  • InjuryJul 14, 2025Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016 DUE TO IMPLANT LOOSENING AND ELEVATED METAL ION LEVELS (CR 40.9 G/L, CO 69.2 G/L). PRE-REVISION EVALUATION ALSO IDENTIFIED OSTEOLYSIS AND PRIOR INFECTION. THE ACETABULAR SHELL WAS REPLACED USING AN R3 SYSTEM WITH CERAMIC-ON-CERAMIC COMPONENTS. NO OPERATIVE REPORT WAS PROVIDED. THE REVISION WAS COMPLETED WITHOUT REPORTED DELAY OR SURGICAL COMPLICATIONS.

    Patient problems: High metal ion levels; Joint Laxity; Medical device site infection; Osteolysis

    MAUDE report 22492960 ↗
  • InjuryJul 8, 2025Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT A PATIENT WHO RECEIVED A LEFT BIRMINGHAM HIP RESURFACING (BHR) IMPLANT ON (B)(6) 2006, DUE TO OSTEONECROSIS, LATER PRESENTED WITH ELEVATED METAL ION LEVELS. THESE FINDINGS SUGGESTED A POTENTIAL ADVERSE LOCAL TISSUE REACTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017, TO ADDRESS THE CONDITION. NO FURTHER INFORMATION AVAILABLE AT THE MOMENT.

    Patient problems: High metal ion levels; Muscle Weakness/Atrophy

    MAUDE report 22433933 ↗
  • InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A REVISION SURGERY OF THE RIGHT HIP 16 YEARS POST-IMPLANTATION DUE TO PAIN AND SUSPICION OF INFECTION. RIGHT HIP ASPIRATION YIELDED NO FLUID. SPECT/CT SHOWED NO EVIDENCE OF INFECTED RIGHT HIP ARTHROPLASTY. THERE WAS NO EVIDENCE OF INFECTION THROUGHOUT ALL OF THE DISSECTION PLANES. DURING THE REVISION SURGERY, ALL PRIOR IMPLANTS WERE EXPLANTED AND REPLACED WITH A THA SYSTEM FROM A COMPETITOR WITH SN FEMORAL COMPONENTS. PRIMARY SURGERY WAS A RIGHT BHR.

    Patient problems: Implant Pain

    MAUDE report 19731184 ↗
  • InjuryJul 1, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT AFTER A PRIMARY RIGHT 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 19652142 ↗
  • InjuryJun 8, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR-THA WAS PERFORMED ON (B)(6) 2007, THE PATIENT WAS DIAGNOSED WITH METALLOSIS, AND THEREFORE, THEY UNDERWENT A REVISION SURGERY ON (B)(6)2019, DURING WHICH ALL BHR COMPONENTS WERE EXCHANGED FOR A COMBINATION OF COMPETITOR AND S+N IMPLANTS. PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

    Patient problems: Metal Related Pathology

    MAUDE report 19494888 ↗
  • InjuryFeb 27, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, A LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2009, AND THE PLAINTIFF LATER EXPERIENCED PAIN AND WAS DIAGNOSED WITH ELEVATED METAL IONS. THEREFORE, A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2023 DURING WHICH BOTH BHR COMPONENTS WERE EXCHANGED FOR COMPETITOR DEVICES. DURING THE REVISION, AMORPHOUS TISSUE AROUND PERICAPSULAR TISSUES WAS FOUND, CONSISTENT WITH METAL ION DEPOSITION. THE PLAINTIFF WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Metal Related Pathology

    MAUDE report 18791804 ↗
  • InjuryFeb 19, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, PATIENT UNDERWENT A PRIMARY BHR RESURFACING LEFT HIP SURGERY ON (B)(6) 2007 DUE TO OSTEOARTHRITIS AND LEFT HIP SECONDARY TO ACETABULAR PROTRUSION, AND SUBSEQUENTLY SUFFERED FROM FAILED LEFT HIP RESURFACING, SECONDARY TO METALLOSIS AND CONTINUED PAIN. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2013 TO EXPLANT THE ACETLR CUP HAP 52MM W/ IMPTR AND RESURFACING FEMORAL HEAD 46MM. THERE WAS SOME EVIDENCE OF OSTEOLYSIS AND SOME STAINED TISSUE WITHIN THE MEDIAL ASPECT OF THE ACETABULUM. AN INTRAOPERATIVE X-RAY DEMONSTRATED THAT THE IMPLANTS WERE IN GOOD POSITION. THE +5 HEAD SIZE RESTORED THE PATIENT'S LEG LENGTH AND ALLOWED EXCELLENT MOTION AND EXTENSION AND EXTERNAL ROTATION WITHOUT IMPINGEMENT, AS WELL AS 90 DEGREES OF FLEXION AND 70 DEGREES OF INTERNAL ROTATION. IT WAS STABLE IN THE SLEEPING POSITION. THE PATIENT TOLERATED THE PROCEDURE WELL. POSTOPERATIVE X-RAYS LOOKED VERY SATISFACTORY.

    Patient problems: Metal Related Pathology

    MAUDE report 18735569 ↗
  • InjuryFeb 8, 2024Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT AFTER THE PLAINTIFF UNDERWENT A BHR RIGHT THA SURGERY ON (B)(6) 2009, HE EXPERIENCED IMPLANT PAIN AND ELEVATED ION LEVELS IN BLOOD. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH THE SURGEON FOUND EVIDENCE OF LOCAL TISSUE REACTION, WITH BROWNING SYNOVIUM, INDICATING METALOSIS. WHEN OPENING THE CAPSULE IT WAS REVELED SOME JOINT FLUID AND SIGNIFICANT SYNOVIAL INFLAMMATION AND IRRITATION, BUT NO SIGNS OF LOOSENING OR INFECTION. THE PREVIOUS IMPLANTED DEVICES SEEMED TO BE WELL-FIXED, THEY WERE EXPLANTED AND REPLACED BY ZIMMER IMPLANTS. THE SURGERY OUTCOME WAS VERY GOOD, NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ADDITIONALLY TO THIS, THE PATIENT ALSO HAD A LEFT BHR RESURFACING THA ON (B)(6) 2013 BUT CURRENTLY THERE IS NO INFORMATION THAT SUGGESTS THAT THE PATIENT HAS SUFFERED ANY COMPLICATION AFTER IT. LEFT HIP IS CURRENTLY UNREVISED.

    Patient problems: Metal Related Pathology; Pain

    MAUDE report 18670795 ↗
  • InjuryJan 19, 2024Biocompatibility; Migration; Biocompatibility; Migration

    IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2011, 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 18543454 ↗
  • InjuryNov 29, 2023Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A RIGHT BHR SURGERY PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED PARTICLE DISEASE ALONG WITH COBALT AND CHROMIUM POISONING. THIS WAS DIAGNOSED AFTER A PET SCAN PERFORMED ON (B)(6) 2022. AS A CONSEQUENCE OF THIS, IT WAS REPORTED THAT THE PATIENT HAS QUESTIONABLE LESIONS (MOTH EATEN APPEARANCE WITH ENDOSTEAL SCALLOPING AND POORLY DEFINED MARGINS) OF THE TIBIA AND LOWER FIBULA ON THE RIGHT LEG, INITIALLY THOUGHT TO BE MYELOMA; ALONG WITH THIS, THE PATIENT EXPERIENCED PAIN AND DISTRESS. IT IS UNKNOWN IF THE PATIENT UNDERWENT ANY FURTHER MEDICAL INTERVENTIONS OR THERAPIES TO TREAT THIS CONDITION.

    Patient problems: High metal ion levels; Metal Related Pathology; Osteolysis

    MAUDE report 18234063 ↗
  • InjuryOct 13, 2023Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A RIGHT PRIMARY BHR-THA SURGERY, PERFORMED (B)(6) 2009, THE PLAINTIFF HAD A REVISION SURGERY ON (B)(6) 2021. DURING WHICH A CLEAR GRAYISH FLUID, INDICATIVE OF METAL ON METAL WEAR WAS FOUND; THE ACETABULUM WAS ALSO LOOSE. THE BHR ACETABULAR CUP, MODULAR SLEEVE, AND HEMI HEAD WERE REPLACED FOR AESCULAP COMPONENTS.

    Patient problems: Inadequate Osseointegration; Metal Related Pathology

    MAUDE report 17936209 ↗
  • InjuryOct 13, 2023Biocompatibility; 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 PRIMARY LEFT BHR-THA ON (B)(6) 2011 AND SUBSEQUENTLY SUFFERED FROM LEFT HIP PAIN AND METALLOSIS. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2023. THE ACETABULAR COMPONENT WAS NOTED TO BE GROSSLY LOOSE, THE FEMORAL COMPONENT WAS NOTED TO BE WELL-FIXED. MULTIPLE TISSUE SAMPLES WERE TAKEN, WHICH ALL APPEARED TO BE CONSISTENT WITH INFECTION. THE ACETLR CUP HAP 52MM W/ IMPTR, MODULAR SLEEVE PLUS 0MM (B)(6), SYN POR PLUS HA HO STEM SZ 15 AND HEMI HEAD 46MM WERE EXPLANTED. THE HIP WAS AGAIN NOTED TO BE STABLE THROUGHOUT THE RANGE OF MOTION AND WITH ACCEPTABLE LEG LENGTHS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. NO ACTIVE ABDUCTION WITH POSTERIOR HIP PRECAUTIONS.

    Patient problems: Inadequate Osseointegration; Medical device site infection; Metal Related Pathology; Unspecified Infection

    MAUDE report 17935113 ↗
  • InjurySep 14, 2023Biocompatibility; Biocompatibility

    BILATERAL PATIENT. IT WAS REPORTED THAT THE PLAINTIFF HAD A PRIMARY BHR SURGERY IN THE RIGHT HIP ON (B)(6) 2009 AND A PRIMARY BHR SURGERY IN THE LEFT HIP ON (B)(6) 2011. THE CONTRIBUTION OF THE LEFT BHR SYSTEM TO THE ELEVATED METAL ION LEVELS CAN NOT BE DISCARDED. IT IS UNKNOWN IF AN INTERVENTION OR REVISION SURGERY IS PLANNED FOR THE LEFT HIP SYSTEM.

    Patient problems: Bursitis; High metal ion levels; Pain

    MAUDE report 17749254 ↗
  • InjuryAug 18, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A BHR LEFT HIP RESURFACING WAS PERFORMED ON (B)(6) 2007 DUE TO OSTEOARTHRITIS, THE PATIENT WAS DIAGNOSED WITH POSTERIOR LEFT HIP PSEUDOTUMOR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 TO ADDRESS THE ISSUE, IN WHICH THE HEAD AND THE CUP WERE EXPLANTED AND REPLACED WITH AN R3 ACETABULAR CUP SIZE 54MM, HIGH OFFSET SYNERGY FEM STEM SZ 11 AND A COBALT CHROME FEMORAL HEAD 32MM + 0. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

    Patient problems: Cyst(s); Metal Related Pathology

    MAUDE report 17577551 ↗
  • InjuryAug 18, 2023Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION THA ON THE (B)(6) 2018, DUE TO ALVAL REACTION AND OSTEOLYSIS AT THE ACETABULAR AREA. DURING THE PROCEDURE A BROWNISH FLUID WAS FOUND, SYNOVITIS AT THE CAPSULE, AND CORROSION WAS NOTICED IN THE FEMORAL HEAD. THE INDEX THA WAS PERFORMED ON THE (B)(6) 2018.

    Patient problems: Metal Related Pathology; Synovitis

    MAUDE report 17577536 ↗
  • InjuryJun 5, 2023Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR RESURFACING SYSTEM LEFT HIP CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2008, THE PLAINTIFF REPORTED PAIN AND LACK OF MOBILITY. THIS IS A BILATERAL PATIENT, AND A REVISION SURGERY OF THE RIGHT HIP WAS PERFORMED ON (B)(6) 2020 (COVERED UNDER (B)(4)) DUE TO A METAL RELATED PATHOLOGY. EVEN THOUGH A REVISION SURGERY OF THE LEFT HIP HAS NOT BEEN PERFORMED OR SCHEDULED, THE CONTRIBUTION OF THE LEFT HIP CONSTRUCT CAN NOT BE DISCARDED AS A CONTRIBUTOR OF THE ELEVATED COBALT AND CHROMIUM LEVELS IN BLOOD OF THE PLAINTIFF.

    Patient problems: Ambulation or Postural Difficulties; Infiltration into Tissue; Pain

    MAUDE report 17060633 ↗
  • InjuryMay 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT, AFTER A LEFT BHR SYSTEM THAT HAD BEEN IMPLANTED ON (B)(6)2009 DUE TO LEFT HIP AVASCULAR NECROSIS, THE PLAINTIFF EXPERIENCED AN INCREASED PAIN AND METAL LEVELS, ADVERSE EVENT THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022, IN WHICH WERE REMOVED THE ACETABULAR CUP AND THE FEMORAL HEAD AND REPLACED WITH COMPETITOR DEVICES. NO COMPLICATIONS WERE SEEING AT THAT POINT AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. CURRENT PATIENT CONDITION IN UNKNOWN.

    Patient problems: High metal ion levels; Insufficient Information; Pain

    MAUDE report 16935844 ↗
  • InjuryMay 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT, AFTER A BHR-THA SYSTEM HAD BEEN IMPLANTED ON PLAINTIFF´S RIGHT HIP ON (B)(6) 2012 DUE TO OSTEOARTHRITIS, THE PLAINTIFF EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WILL BE ADDRESSED VIA REVISION SURGERY IN WHICH THE DATE IS STILL PENDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 16935801 ↗
  • InjuryMay 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT, AFTER A RIGHT BHR SYSTEM THAT HAD BEEN IMPLANTED ON (B)(6) 2010 DUE TO RIGHT HIP AVASCULAR NECROSIS, THE PLAINTIFF EXPERIENCED AN INCREASED PAIN AND METAL LEVELS, ADVERSE EVENT THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022, IN WHICH WERE REMOVED THE ACETABULAR CUP AND THE FEMORAL HEAD AND REPLACED WITH COMPETITOR DEVICES. NO COMPLICATIONS WERE SEEING AT THAT POINT AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. CURRENT PATIENT CONDITION IN UNKNOWN.

    Patient problems: High metal ion levels; Insufficient Information; Pain

    MAUDE report 16928308 ↗
  • InjuryApr 26, 2023Biocompatibility; 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 ELEVATED WHOLE-BLOOD METAL-IONS AT 4TH YEAR. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY 62 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: Metal Related Pathology

    MAUDE report 16820406 ↗
  • InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A TOTAL LEFT HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2016 THE PATIENT EXPERIENCED AN INFECTION. FOR THIS REASON, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH THE ACETLR CUP HAP 52MM W/ IMPTR, THE SPEC EF PRIM HO 12/14 SZ 3 AND THE MODULAR HEAD 46 MM -4 (SHORT) WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 16771178 ↗
  • InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A TOTAL RIGHT HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2016 THE PATIENT EXPERIENCED AN INFECTION. FOR THIS REASON, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH THE ACETLR CUP HAP 52MM W/ IMPTR, THE SPEC EF PRIM HO 12/14 SZ 3 AND THE MODULAR HEAD 46 MM -4 (SHORT) WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Medical device site infection; Unspecified Infection

    MAUDE report 16747035 ↗
  • InjuryJun 11, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT, AFTER A BHR SYSTEM WAS IMPLANTED ON (B)(6) 2005 DUE TO ARTHROSIS, THE PATIENT EXPERIENCED METALLOSIS AND PAIN. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Metal Related Pathology; Pain

    MAUDE report 14670221 ↗

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-0033-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. 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-0017-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. 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-0018-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. 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-0029-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. 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-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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