BHR 74122552Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556071694), received between Oct 14, 2019 and Jun 25, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Biocompatibility” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHRMH IN HIS RIGHT HIP JOINT ON (B)(6) 2010, PATIENT EXPERIENCED FAILURE OF RIGHT METAL-ON-METAL TOTAL HIP REPLACEMENT WITH METAL TOXICITY. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY. WHILE DOING THE PROCEDURE THEY ENCOUNTERED SIGNIFICANT AMOUNTS OF NECROTIC APPEARING SYNOVIUM WHICH WAS EXCISED. THIS WAS EXCISIONAL IN NATURE. ALSO, THERE WAS SOME DEBRIS AND CORROSION ON THE TRUNNION. FINALLY, PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology; Necrosis

  MAUDE report 22326545 ↗
• InjuryFeb 9, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PRIMARY RIGHT THA-BMHM WAS PERFORMED ON (B)(6) 2008. THE PLAINTIFF WAS LATER DIAGNOSED WITH METALLOSIS; THEREFORE, A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2023, DURING WHICH CORROSION OF THE FEMORAL HEAD WITH NO APPARENT MUSCLE DAMAGE WAS FOUND. THE HEMI HEAD 52MM AND MODULAR SLEEVE {} PLUS 0MM 12/14 WERE EXCHANGED FOR AN OXINIUM DUAL MOBILITY FEMORAL HEAD, AND THE ACETABULAR SHELL AND FEMORAL STEM WERE UNCHANGED. AFTER SURGERY THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION, NO OTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 18681581 ↗
• InjuryFeb 9, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP BHR-THA SURGERY ON (B)(6) 2009, THE PATIENT EXPERIENCED UNSPECIFIED METAL-RELATED COMPLICATIONS. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022. ADDITIONALLY, ON (B)(6) 2022, THE PATIENT UNDERWENT A POSTERIOR CAPSULE MESH RECONSTRUCTION TO REPAIR EXTENSIVE DAMAGE TO THE HIP.

  Patient problems: Insufficient Information

  MAUDE report 16342786 ↗
• InjuryMay 30, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER RIGHT BHR SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INCREASING METAL LEVELS, PAIN, THICKENING, INFLAMMATION AND A PSEUDOTUMOR. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inflammation; Metal Related Pathology; Pain; Solid Tumor

  MAUDE report 14542489 ↗
• InjuryMay 27, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN, METALLOSIS, TRUNNIONOSIS AND LOWER EXTREMITY SWELLING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR HEMI HEAD WAS REMOVED FROM THE TRUNNION AND REPLACED WITH A 28+ OXINIUM HEAD AND A DUAL MOBILITY INSERT THAT MATCHED THE ORIGINAL 52MM BHR ACETABULAR CUP. DVT PROPHYLAXIS MEDICATION AND BROAD-SPECTRUM ANTIBIOTICS WERE ADMINISTERED AFTER CONCLUDING THIS PROCEDURE.

  Patient problems: Arthralgia; Metal Related Pathology; Swelling/ Edema

  MAUDE report 14527839 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A BHR THA SURGERY HAD BEEN PERFORMED IN THE RIGHT HIP ON (B)(6) 2010, THE PATIENT HAD A MINOR FALL ON (B)(6) 2019, PROVOKING A RIGHT HIP ISCHIUM FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THE ADVERSE EVENT; INTRAOPERATIVELY IT WAS FOUND THAT THERE WAS SIGNIFICANT METALLOSIS WITH TRUNNIONOSIS ON THE TAPER, WITH BLACK CORROSION AT THE HEAD AND TAPER JUNCTION OF THE FAILED IMPLANT; AND ALSO SIGNIFICANT INFLAMMATORY TISSUE AT THE ACETABULUM'S PERICAPSULAR TISSUE. THE PATIENT OUTCOME IS UNKNOWN.

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

  MAUDE report 10440286 ↗
• InjuryAug 21, 2020Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENTS LEFT HIP DUE TO FAILED LEFT TOTAL HIP ARTHOPLASTLY SECONDARY TO METALOSIS FROM METAL ON METAL ARTICULATION AND TRUNNIONOSIS, EVIDENCE OF METALOSIS IN THE LEFT HIP WITH BOTH A PSEUDOTUMOR AND SEVERE TRUNNIONOSIS.

  Patient problems: Bone Fracture(s); Cyst(s); Foreign Body Reaction; Metal Related Pathology

  MAUDE report 10440264 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LEFT HIP REVISION WAS PERFORMED DUE TO PAINFUL METAL-ON-METAL TOTAL HIP ARTHROPLASTY, AND TRUNNIONOSIS.

  Patient problems: No Code Available; Pain

  MAUDE report 9955673 ↗
• InjuryFeb 3, 2020Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A LEFT HIP REVISION DUE TO DRAMATIC SYNOVIAL FLUID, PAIN AND PSEUDOTUMOR.

  Patient problems: Pain; Swelling

  MAUDE report 9659113 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LEFT HIP REVISION WAS PERFORMED DUE TO SEPTIC HIP, AND METALLOSIS.

  Patient problems: Injury; Sepsis; Toxicity

  MAUDE report 9183978 ↗