BHR 74122540Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556070116), received between Nov 26, 2020 and Jun 13, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Biocompatibility” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER AN R3-THA CONSTRUCT HAD BEEN IMPLANTED ON AN UNSPECIFIED DATE, THE PATIENT STARTED EXPERIENCING PAIN. ELEVATED COBALT LEVELS WERE DETECTED. A REVISION SURGERY WAS PERFORMED ON (B)(6)2023 TO ADDRESS THIS EVENT. THE R3 METAL LINER, THE HEMI HEAD, AND THE SLEEVE WERE EXPLANTED AND REPLACED WITH OR3O DUAL MOBILITY BEARINGS. THE SHELL AND STEM WERE RETAINED. CURRENT PATIENT HEALTH STATUS IS UNKNOWN.

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

  MAUDE report 17121472 ↗
• InjuryMay 18, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A REVISION SURGERY OF THE RIGHT HIP DUE TO ELEVATED COBALT AND CHROMIUM LEVELS IN BLOOD, AND WEAR OF ARTICULAR BEARING SYSTEM. DURING THE REVISION SURGERY, THE METALLIC CUP, MODULAR FEMORAL HEAD, AND MODULAR SLEEVE WERE EXPLANTED AND REPLACED WITH A COMPETITOR´S SYSTEM. THE PRIMARY STEM WAS NOT EXPLANTED. INTRAOPERATIVE FINDINGS INCLUDED A SMALL PSEUDOCYST IN THE LATERAL REGION, AND REACTIVE SYNOVITIS TO THE SYNOVIUM OF THE JOINT. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PRIMARY BHR THA SURGERY WAS PERFORMED ON (B)(6) 2009.

  Patient problems: Infiltration into Tissue; Metal Related Pathology

  MAUDE report 16957874 ↗
• InjuryMay 13, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT REVISION SURGERY ON (B)(6) 2022 DUE TO A FAILED HIP ARTHROPLASTY SECONDARY TO METALLOSIS, AND NEUROLOGIC SYMPTOMS. THE PRIMARY RIGHT HIP SURGERY WAS PERFORMED ON (B)(6) 2010. DURING THE REVISION SURGERY, TRUNNION WITH MINIMAL CORROSION WAS FOUND. THE SURGEON DECIDED TO REPLACE THE METAL LINER AND THE MODULAR FEMORAL HEAD, AND TO RETAIN THE PRIMARY CUP AND FEMORAL COMPONENT. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Infiltration into Tissue

  MAUDE report 16926970 ↗
• InjuryFeb 14, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT HIP REVISION SURGERY ON (B)(6) 2021 DUE TO METALLOSIS, WITH PURULENT LOOKING FLUID PRESENT. THE PATIENT ALSO PRESENTED HIP PAIN, ELEVATED SEROLOGY, AND FRACTURE OF HIS LESSER TROCHANTER. DURING THE REVISION SURGERY, ABUNDANT GREENISH/YELLOWISH FLUID WAS NOTICED IN THE HIP. A THOROUGH DEBRIDEMENT WAS PERFORMED, AND ALL THE COMPONENTS WERE EXPLANTED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PRIMARY RIGHT THA WAS PERFORMED ON (B)(6) 2011.

  Patient problems: Arthralgia; Hip Fracture; Metal Related Pathology

  MAUDE report 16372587 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER RIGHT R3-THA WAS PERFORMED ON (B)(6) 2010 DUE TO RIGHT SEVERE OSTEOARTHRITIS, THE PATIENT EXPERIENCED DEGENERATIVE CHANGES AND MILD SYNOVIAL HYPERPLASIA. THIS ADVERSE EVENT WAS TREATED WITH A REVISIONS SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Hyperplasia

  MAUDE report 14466398 ↗
• InjuryMay 21, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT R3-THA WAS PERFORMED ON (B)(6) 2009 DUE TO HIP ARTHRITIS, THE PATIENT EXPERIENCED PAIN, METALLOSIS AND TRUNIONOSIS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, IN WHICH SIGNIFICANT METALLOSIS IN THE HIP WAS FOUND. MOST OF METALLOSIS WAS GENERATED BETWEEN THE CUP AND METAL LINER. IN ADDITION, A SIGNIFICANT PSEUDOTUMOR WAS OBSERVED, WHICH WAS DEBRIDED. FURTHERMORE, THE ACETABULAR COMPONENT WAS RETROVERTED BY FEW DEGREES. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14466092 ↗
• 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) 2019 (2ND STAGE). DURING THE SECOND STAGE THE ZIMMER STEM WAS REMOVED AGAIN ALONG WITH THE BHR-THA SHELL, HEAD AND SLEEVE. 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; Failure of Implant; Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 10908808 ↗