BHR 74122542Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00885556070710), received between Apr 6, 2020 and Oct 6, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Biocompatibility” (16 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING A BHR-THA ON (B)(6) 2011 DUE TO A FAILED LEFT HIP RESURFACING. PATIENT SUFFERED FROM METAL-ON-METAL DISEASE. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH SURGEON DID A HEAD EXCHANGE AND CONVERSION TO A DUAL MOBILITY. UPON INSPECTING THE SOFT TISSUE STRUCTURE, THERE WAS NO EVIDENCE OF SOFT-TISSUE STRUCTURE EROSION. THE ABDUCTOR TENDONS WERE HEALTHY· APPEARING WITHOUT ANY EVIDENCE OF WEAR. THERE WAS NO PSEUDOTUMOR THAT WAS THEN VISUALIZED THROUGH THE APPROACH THAT WE WERE ABLE TO IDENTIFY. UPON ENTERING THE JOINT, THERE WAS SOME DUSKY METAL DISEASE. IT WAS NOTED PRIMARILY WHAT APPEARED TO BE FROM THE SOURCE OF TRUNNIONOSIS. THE FEMORAL HEAD WAS REMOVED, AND THE TRUNNION SLEEVE HAD SOME BACKSIDE WEAR WHERE SURGEON MATED WITH THE FEMORAL HEAD. SKIN WAS CLOSED WITH STAPLE. STERILE DRESSING WAS APPLIED. THE PATIENT WAS AWOKEN FROM GENERAL ANESTHESIA AND TRANSFERRED TO THE PACU IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 23221730 ↗
• InjuryDec 5, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR REVISION WAS PERFORMED ON (B)(6) 2010, PATIENT EXPERIENCED PAIN SINCE 2021 AND MECHANICAL FAILURES IN 2023. TESTS LATER REVEALED ELEVATED COBALT AND CHROMIUM LEVELS, OSTEOLYSIS AROUND THE GREATER TROCHANTER, AND THEY WERE DIAGNOSED WITH ADVERSE LOCAL TISSUE REACTION. THEREFORE, THEY UNDERWENT A REVISION SURGERY ON (B)(6) 2024. DURING SURGERY, BLACK AND SYNOVITIS BOTH THROUGHOUT THE CUP AND AROUND THE ACETABULUM WAS FOUND AND SUBSEQUENTLY DEBRIDED. ALL BHR COMPONENTS WERE EXCHANGED FOR A STRYKER SHELL AND BIOLOX CERAMIC HEAD. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE PACU IN STABLE CONDITION.

  Patient problems: Memory Loss/Impairment; Metal Related Pathology; Pain; Peripheral Nervous Injury

  MAUDE report 20854551 ↗
• InjuryJun 8, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT HIP REVISION SURGERY ON (B)(6) 2021 DUE TO METALLOSIS. INTRA-OPERATIVE FINDINGS INCLUDED A MILD-TO-MODERATE AMOUNT OF NECROSIS AND CORROSION AT THE TRUNNION. THE STEM AND THE CUP WERE WELL FIXED, ONLY THE MODULAR HAD AND HEAD SLEEVE WERE EXPLANTED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. 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; Metal Related Pathology; Necrosis

  MAUDE report 17092359 ↗
• InjuryMay 15, 2023Biocompatibility; Insufficient Device Problem Information; Biocompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP ARTHROPLASTY PERFORMED ON THE LEFT HIP ON THE (B)(6) 2011 DUE TO OSTEOARTHRITIS. AFTER THE TOTAL HIP ARTHROPLASTY, THE PATIENT DECIDED TO UNDERGO REVISION SURGERY ON (B)(6) 2023, WHERE THE FEMORAL HEAD AND SLEEVE WERE EXPLANTED. DURING THE PROCEDURE, METALLOSIS WAS FOUND, WITH MINIMAL CAPSULAR NECROSIS AND MILD CORROSION ON THE FEMORAL TRUNNION, TAPER ADAPTER, AND INTERNAL PORTION OF THE FEMORAL HEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 16935809 ↗
• InjuryMay 15, 2023Biocompatibility; Insufficient Device Problem Information; Biocompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER UNDERGOING TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2011 DUE TO OSTEOARTHRITIS, THE PATIENT DECIDED TO UNDERGO REVISION SURGERY OF THE RIGHT IMPLANTS ON (B)(6) 2023, IN WHICH THE FEMORAL HEAD AND SLEEVE WERE EXPLANTED. DURING THE PROCEDURE, METALLOSIS AND MILD CORROSION WERE FOUND. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 16935771 ↗
• InjuryAug 10, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF HAD A LEFT TOTAL HIP ARTHROPLASTY (BHR MODULAR SYSTEM-HEMI HEADS) ON (B)(6) 2009 DUE TO OSTEOARTHRITIS. ON (B)(6) 2021 THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE LINER AND THE HEAD WERE EXPLANTED DUE TO METALLOSIS ON THE LEFT HIP. THE CURRENT STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 15203364 ↗
• InjuryJul 10, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT BHR ON (B)(6) 2008 DUE TO ARTHRITIS. PLAINTIFF IMPLANTS FAILED AND PRESENTED A PSEUDOTUMOR. PLAINTIFF UNDERWENT RIGHT REVISION SURGERY ON (B)(6) 2020 WHERE COMPROMISE AND NECROSIS OF THE POSTERIOR THIRD OF THE G. MEDIUS AND COMPLETE NECROSIS OF THE G. MINIMUS WERE NOTED. THE PSEUDOTUMOR WAS WITHIN THE JOINT AND AROUND THE GREATER TROCHANTERIC BURSA WHICH WAS DEBRIDED. THERE WAS SOME METALLOSIS IN THE SOFT TISSUES OF THE POSTERIOR JOINT CAPSULE. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Metal Related Pathology; Necrosis

  MAUDE report 14973820 ↗
• InjuryJun 11, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED OSTEOLYSIS AROUND HER PELVIS AND LOOSENING OF THE ACETABULAR COMPONENT FOLLOWING A METALLOSIS DIAGNOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE POSTERIOR HIP CAPSULE HAD STAINING CONSISTENT WITH A GRAY METALLOSIS, AND THE JOINT PRESENTED SOME GRAYISH FLUID AND SIGNIFICANT GRAY AND BLACK STAINING TO THE SOFT TISSUE. SOME OSTEOLYSIS ALONG THE POSTERIOR FEMORAL SHAFT IN THE METAPHYSEAL REGION WAS ALSO NOTED. UPON REMOVING THE BHR MODULAR FEMORAL HEAD AND CUP, THE SURGEON FACED SEVERAL DIFFICULTIES WHILST FIXING A 56MM ACETABULAR CUP AND WAS NOT SATISFIED WITH THE OUTCOME, AS A PROPERLY FIXATION COULD HAD BEEN COMPROMISED MAINLY DUE TO THE DEFICIENT CONDITION OF THE MEDIAL, ANTERIOR AND POSTERIOR WALL OF THE ACETABULUM. BECAUSE OF THIS, HE DECIDED TO PLACE THE NEW IMPLANTS AND CLOSE THE INCISION TO FURTHER PLAN A CAGED RECONSTRUCTION OF THE ACETABULUM. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14670396 ↗
• InjuryJun 8, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT BHR-THA SURGERY WAS PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN AT THE HIP JOINT AND ELEVATED COBALT AND CHROMIUM LEVELS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE BHR MODULAR HEAD WAS REMOVED FROM THE SYSTEM AND REPLACED WITH A SMITH AND NEPHEW DUAL MOBILITY LINER AND A 28MM +4 OXINIUM HEAD. INTRAOPERATIVELY, THE ACETABULAR COMPONENT WAS NOTED TO BE IN GOOD POSITION AND WITHOUT ANY EVIDENCE OF LOOSENING. THE TRUNNION PRESENTED A SMALL AMOUNT OF CORROSION IN THE MID DISTAL REGION BUT WAS OVERALL IN GOOD SHAPE. THE PATIENT WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT WITHOUT ANY COMPLICATIONS.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14634321 ↗
• InjuryMay 29, 2022Biocompatibility; Biocompatibility

  US LEGAL. BILATERAL PATIENT. IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A LEFT HIP REVISION SURGERY ON (B)(6) 2021 DUE TO COBALT TOXICITY AND FAILED THA. DURING THE REVISION SURGERY, THE FEMORAL HEAD AND NECK WERE EXPLANTED AND REPLACED WITH A PLASTIC INSERT AND AN OXINIUM FEMORAL HEAD. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THE PRIMARY BHR THA PROCEDURE WAS PERFORMED ON (B)(6) 2009.

  Patient problems: Metal Related Pathology

  MAUDE report 14539032 ↗
• InjuryMay 23, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER AN R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2009, THE PATIENT EXPERIENCED METALLOSIS AND PAIN. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH A COMPETITORS¿ THA SYSTEM. INTRAOPERATIVELY, INFLAMMATORY SYNOVIAL CHANGES WERE NOTICED WITH A SMALL GROSS MACROSCOPIC AREA WITH TISSUE STAINING. THE TRUNNION SHOWED MILD SIGNS OF CORROSION. THE PATIENT WAS TRANSFERRED IN A STABLE CONDITION TO THE RECOVERY ROOM.

  Patient problems: Metal Related Pathology; Pain; Synovitis

  MAUDE report 14467838 ↗
• InjuryMay 19, 2022Biocompatibility; Biocompatibility

  US LEGAL: IT WAS REPORTED THAT, AFTER PRIMARY LEFT R3 THA SURGERY WAS PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED METALLOSIS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION, DARK METALLIC FLUID WAS FOUND IN THE HIP. THE METALLIC LINER, FEMORAL HEAD AND FEMORAL HEAD SLEEVE WERE EXPLANTED AND REPLACED WITH A CERAMIC AND POLY ARTICULATION SYSTEM. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 14438404 ↗
• InjuryOct 22, 2021Biocompatibility; Biocompatibility

  US LEGAL, IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A SECOND REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2019 DUE A METAL RELATED PATHOLOGY. DURING THE SURGERY, EVIDENCE OF SIGNIFICANT OSTEOLYSIS AND METALOSIS WAS FOUND, AND THE METALLIC CUP AND FEMORAL HEAD WERE EXPLANTED. AFTER THE REVISION, THE PATIENT WAS DIAGNOSED WITH ¿COBALT CARDIOMYOPATHY¿ AND SUFFERED SEVERE COMPLICATIONS RELATED TO PROGRESSIVE CARDIOGENIC SHOCK, ACUTE RENAL FAILURE WITH HYPERKALEMIA, HYPONATREMIA, AND METABOLIC ACIDOSIS. THIS ISSUE HAS NOT BEEN RESOLVED.

  Patient problems: Metal Related Pathology

  MAUDE report 12681794 ↗
• InjurySep 9, 2021Biocompatibility; Biocompatibility

  US LEGAL MDL. IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2010, THE PLAINTIFF EXPERIENCED ELEVATED METAL ION LEVELS, PAIN, A LATERAL FLUID COLLECTION AND PSEUDOTUMOR FORMATION ALONG THE POSTERIOR CAPSULE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Infiltration into Tissue; Metal Related Pathology; Pain

  MAUDE report 12446749 ↗
• InjurySep 1, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR THA CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF'S RIGHT HIP ON (B)(6) 2007, THE PLAINTIFF EXPERIENCED PAIN, ELEVATED METAL LEVELS, METALLOSIS, DIFFICULTY WALKING, LACK OF MOBILITY, GAIT ISSUES AND BACK PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THE REVISION, THE CUP AND STEM WERE WELL FIXED AND WERE LEFT IN PLACE. THE MODULAR HEAD WAS EXPLANTED AND REPLACED WITH A BIOMET DUAL MOBILITY SYSTEM. THE PLAINTIFF'S OUTCOME IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Bursitis; High metal ion levels; Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 12411038 ↗
• InjuryAug 19, 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 LEFT BHR THA CONSTRUCTS HAD BEEN IMPLANTED ON (B)(6) 2010 AS A PART OF A FIRST REVISION SURGERY, THE PLAINTIFF EXPERIENCED MECHANICAL COMPLICATIONS AND COBALT AND CHROMIUM TOXICITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. THERE WAS SOME METALLOSIS FOUND AT THE TRUNNION. THERE WAS SOME OSTEOLYSIS FOUND IN THE ACETABULUM. THE METAL FEMORAL HEAD WAS REVISED TO A DUAL MOBILITY POLY INSERT WITH AN OXINIUM FEMORAL HEAD. THE CUP AND THE STEM WERE NOT EXPLANTED.

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

  MAUDE report 12344383 ↗
• InjuryJul 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A BHR SURGERY WAS PERFORMED ON (B)(6) 2008, A REVISION SURGERY HAD TO BE CONDUCTED ON (B)(6) 2021 DUE TO METAL ON METAL PAIN. A MODULAR SLEEVE +8MM 12/14, A HEMI HEAD 42MM, AND A ACETLR CUP HAP 48MM W/ IMPTR WERE EXPLANTED. PATIENT OUTCOME REMAINS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 12143288 ↗
• InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO BLACK CORROSION/ METALLOSIS ON THE FEMORAL NECK TAPER AND LINER TAPER.

  Patient problems: Metal Related Pathology

  MAUDE report 11376890 ↗
• InjuryJan 13, 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 RIGHT HIP ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED DUE TO DIFFICULTY WALKING AND PERFORMING OTHER PHYSICAL ACTIVITIES; LOSS OF RANGE OF MOTION AND STIFFNESS, EXHAUSTION FROM PAIN, DIFFICULTY PERFORMING ACTIVITIES OF DAILY LIFE; DIFFICULTY SLEEPING; PAIN IN THE RIGHT HIP; METALLOSIS; ADVERSE REACTION TO METAL DEBRIS; AND ELEVATED LEVELS OF METAL IONS IN BLOOD. AMONG THE INTRAOPERATIVE FINDINGS THERE WAS A REVISION ACETABULAR COMPONENT DUE TO WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC OF RIGHT HIP JOINT, EVIDENCE OF TRUNNIONOSIS AND THICKENED AVASCULAR TISSUE EVIDENT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain; Sleep Dysfunction

  MAUDE report 11167253 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BILATERAL PATIENT. PLAINTIFF UNDERWENT MEDICALLY-INDICATED TWO-STAGE REVISION OF THE BHR-THA LEFT HIP IMPLANTS ON (B)(6) 2018. (1ST STAGE) AND (B)(6) 2018 (2ND STAGE). ON THE FIRST STAGE THE STEM, FEMORAL HEAD AND SLEEVE WERE REMOVED. AT THE SECOND STAGE THE ZIMMER COMPONENTS WERE REMOVED ALONG WITH THE BHR-THA SHELL. THE PATIENT REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN, LIMITED MOBILITY, METALLOSIS, PSEUDOTUMOR FORMATION, AND ELEVATED COBALT AND CHROMIUM ION LEVELS. NO S&N PARTS REMAINED IMPLANTED.

  Patient problems: Bacterial Infection; Metal Related Pathology; Pain

  MAUDE report 10909147 ↗
• InjuryNov 22, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN ASSOCIATED TO A POSSIBLE METAL RELATED PATHOLOGY. AN R3 THA SYSTEM WAS REVISED DURING THIS PROCEDURE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 10882215 ↗
• InjuryJul 30, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION HIP SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO ELEVATED HIP EFFUSION. ALSO, SERUM COBALT BLOOD WORK REPORT SHOWED ELEVATED COBALT AND CHROMIUM LEVEL. THE MODULAR METAL HEAD, THE SLEEVE AND THE R3 METAL LINER WERE EXPLANTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Metal Related Pathology

  MAUDE report 10347385 ↗
• InjuryApr 6, 2020Therapeutic or Diagnostic Output Failure; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A RIGHT HIP REVISION SURGERY DUE TO A SEVERE FAILURE OF THE RIGHT TOTAL HIP ARTHROPLASTY, ADVANCE ALVAL (PSEUDOTUMOR, ASEPTIC LYMPHOCYTIC VASCULITIC-ASSOCIATED LESION).

  Patient problems: Failure of Implant; Injury; No Code Available

  MAUDE report 9930145 ↗