BHR 74122554Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556071854), received between Nov 25, 2019 and Apr 5, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Biocompatibility” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BILATERAL INDEX BHR RESURFACING SURGERY ON THE (B)(6) 2007. THE PATIENT EXPERIENCED ELEVATED METAL ION LEVELS. THE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2023, DURING WHICH THE METAL HEAD AND SLEEVE WERE EXPLANTED AND REPLACED BY AN OXINIUM FEMORAL HEAD AND A DUAL MOBILITY LINER. THIS PATIENT ALSO UNDERWENT A REVISION SURGERY OF THE LEFT HIP TO ADDRESS THE ISSUE.

  Patient problems: High metal ion levels

  MAUDE report 19051134 ↗
• InjuryFeb 26, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2023 DUE TO ELEVATED METAL IONS. DURING THE REVISION SURGERY, MODERATE CORROSION WAS FOUND AT THE MODULAR HEAD NECK JUNCTION. THE FEMORAL HEAD WAS EXPLANTED AND REPLACED. THE CUP WAS FOUND TO BE WELL FIXED AND WAS LEFT IN PLACE. THE PRIMARY RIGHT HIP BHR-THA PRIMARY SURGERY ON (B)(6) 2009. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Metal Related Pathology

  MAUDE report 18778546 ↗
• InjuryFeb 5, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP BHR-THA REPLACEMENT ON (B)(6) 2009. AFTER THIS PROCEDURE, A TEST PERFORMED ON (B)(6) 2020 INDICATED AN INCREASE IN COBALT ION LEVELS IN BLOOD OF 4 NG/ML, WHICH DECREASED TO 3.6 NG/ML IN AN ADDITIONAL TEST PERFORMED ON (B)(6) 2022. ON (B)(6) 2023 THE COBALT AND CHROMIUM LEVELS WERE 3.4 AND 7.9 NG/ML. THE PATIENT HAD AN ORTHOPEDIC FOLLOW-UP ON (B)(6) 2019 FOR RIGHT HIP PAIN, IT IS NOTED X-RAY SHOWED METAL ON METAL RIGHT TOTAL HIP ARTHROPLASTY WITH METAL TAPER STEM AND SOME DEGREE OF OSTEOPENIC CHANGES OF THE GREATER TROCHANTER . A REVISION SURGERY WAS SCHEDULED (B)(6) 2023 HOWEVER, IT¿S NOTED BEFORE HIS SCHEDULED REVISION, THE PATIENT FELL ON HIS RIGHT HIP AND SUSTAINED A PERIPROSTHETIC FRACTURE AROUND THE INTERNAL PROSTHETIC HIP JOINT. HIS REVISION WAS POSTPONED FOR 8 WEEKS NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: Arthralgia; Bone Fracture(s); High metal ion levels; Osteolysis

  MAUDE report 18646825 ↗
• InjuryAug 30, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY OF COMPETITOR DEVICES, DUE TO HIP PAIN ON (B)(6) 2008 WHERE A BHR ACETABULAR CUP, MODULAR SLEEVE, AND HEMI HEAD WERE IMPLANTED. AFTER THE REVISION SURGERY, THE PATIENT STARTED TO PRESENT SYMPTOMS OF PAIN, OSTEOLYSIS AND MILDLY ELEVATED METAL IONS. THESE ADVERSE EVENTS WERE DECIDED TO BE TREATED WITH ANOTHER REVISION SURGERY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A DARK METAL STAINED PSEUDOCAPSULE WAS NOTICED, WITH EVIDENCE OF TRUNNIONOSIS. THE PATIENT WAS THEN TRANSFERRED TO THEIR BED IN STABLE CONDITION HAVING TOLERATED THE PROCEDURE WELL.

  Patient problems: Metal Related Pathology

  MAUDE report 17657777 ↗
• InjuryMay 15, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A TOTAL HIP ARTHROPLASTY PERFORMED ON (B)(6) 2009, THE PATIENT SHOWS ELEVATED METAL IONS IN HIS BLOOD AND ELEVATED C-REACTIVE PROTEIN (CRP) AND ESR AND ASPIRATION OF THE RIGHT HIP SHOWED OVER 100,000 WITH CELLS WITH A POSITIVE CULTURE. THESE ADVERSE EVENTS WERE TREATED VIA REVISION SURGERY THAT WAS PERFORMED ON (B)(6) 2022. DURING THE REVISION SURGERY WAS NOTICED SIGNIFICANT METALLOSIS INVOLVING THE SOFT TISSUE AROUND THE GREATER TROCHANTER, THERE WAS ALSO SIGNIFICANT OSTEOLYSIS DUE TO THIS METALLOSIS OF THE PROXIMAL FEMUR. ALL IMPLANTS WERE EXPLANTED AND REPLACE WITH A PROSTALAC SYSTEM (COMPETITOR IMPLANTS). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: High metal ion levels; Insufficient Information; Medical device site infection; Metal Related Pathology; Osteolysis; Unspecified Infection

  MAUDE report 16935902 ↗
• InjuryMay 11, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BILATERAL INDEX BHR RESURFACING SURGERY ON THE (B)(6) 2007, THE PATIENT WAS NOTED TO HAVE ELEVATED LEVELS OF COBALT AND CHROMIUM. A LEFT HIP REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022, ON WHICH THE FEMORAL HEAD WAS EXPLANTED AND EXCHANGE WITH A DUAL MOBILITY LINER AND AN OXINIUM FEMORAL HEAD. THE PATIENT SUPPORTED THE PROCEDURE WELL WITHOUT ANY COMPLICATIONS.

  Patient problems: Infiltration into Tissue

  MAUDE report 16911559 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CONVERSION TO BHR-THA HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT PRESENTED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO CONVERT TO A BHR DUAL MOBILITY HIP: THE BHR CUP AND THE ANTHOLOGY STEM WERE RETAINED AS WERE WELL FIXED, WHILE THE HEMI HEAD 54MM AND SLEEVE WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 16746730 ↗
• InjuryOct 19, 2022Biocompatibility; Biocompatibility

  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 HIP PAIN, ELEVATED METAL IONS AND PSEUDOTUMOR ON MRI CONCERNING FOR ALVAL. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE 54 MM MODULAR HEAD AND THE 0MM SLEEVE WERE EXPLANTED AND REPLACED WITH AN OXINIUM HEAD AND A DUAL MOBILITY LINER. INTRAOPERATIVELY, A PURULENT LOOKING FLUID ASSOCIATED WITH ALVAL REACTION WAS IDENTIFIED UPON ENTERING THE CAPSULE. THE PATIENT WAS AWAKENED AND TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 15636019 ↗
• InjuryMay 12, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR-THA ON (B)(6) 2007 DUE TO SEVERE DEGENERATIVE OSTEOARTHRITIS, LEFT HIP COXA VARA, CHRONIC FEMORAL IMPINGEMENT, AND POST SCFE DEFORMITY. PLAINTIFF EXPERIENCES SWELLING AND HIGH COBALT LEVELS. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2021 WHERE THE MODULAR HEAD AND STEM WAS REMOVED, AND DEBRIDEMENT OF ALL FIBRINOUS AND INFECTED TISSUE WAS PERFORMED BUT DUE TO PATIENT¿S CARDIOPULMONARY STATUS IT WAS REQUIRED TO CLOSED AND WAIT FOR PATIENT STABILIZATION. REVISION SURGERY WAS RESUME ON (B)(6) 2021 WHERE AN ACETABULAR COMPONENT WAS REMOVED, AND IT WAS FOUND A LARGE SUPERIOR CYST INSIDE THE ILIUM. PATIENT STATUS IS UNKNOWN.

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Infiltration into Tissue; Metal Related Pathology; Swelling/ Edema; Unspecified Infection

  MAUDE report 14385569 ↗
• InjuryApr 19, 2022Biocompatibility; Biocompatibility

  US LEGAL: IT WAS REPORTED THAT, AFTER A LEFT BHR-THA WAS PERFORMED ON (B)(6) 2011 DUE TO HYPERTROPHIC OSTEOARTHRITIS, THE PATIENT EXPERIENCED A LEFT INFECTION AND INFLAMMATORY REACTION DUE TO ELEVATED SERUM COBALT AND CHROMIUM LEVELS. THIS ADVERSE EVENT WAS TREATED WITH A LEFT REVISION SURGERY ON (B)(6) 2021, IN WHICH A SPACER REPLACEMENT/SYNOVECTOMY, BONE EXCISION AND A TROCHANTERIC OSTEOTOMY REPAIR WERE PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fistula; Fluid Discharge; Metal Related Pathology; Unspecified Infection

  MAUDE report 14140541 ↗
• InjuryApr 19, 2022Biocompatibility; Biocompatibility

  US LEGAL: IT WAS REPORTED THAT, AFTER A RIGHT BHR-THA WAS PERFORMED ON (B)(6) 2011 DUE TO HYPERTROPHIC OSTEOARTHRITIS, THE PATIENT EXPERIENCED ELEVATED SERUM COBALT AND CHROMIUM LEVELS. PLAINTIFF UNDERWENT A LEFT REVISION SURGERY ON (B)(6) 2021 ((B)(4)). IT IS UNKNOWN IF A RIGHT REVISION SURGERY HAS BEEN PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Infiltration into Tissue; Metal Related Pathology

  MAUDE report 14140534 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENTS LEFT HIP ON (B)(6) 2019, DUE SEVERE PAIN, LIMITED MOBILITY, METALLOSIS, ELEVATED COBALT AND CHROMIUM LEVELS, AND TRUNNIONOSIS. AMONG THE INTRA-OPERATIVE FINDINGS AND DIAGNOSES WERE: ELEVATED COBALT AND CHROMIUM LEVELS, TRUNNIONOSIS AND METALLOSIS AS A RESULT OF THE PREMATURE FAILURE OF THE DEVICES. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Limited Mobility Of The Implanted Joint; Metal Related Pathology; Pain; Toxicity

  MAUDE report 10582549 ↗
• InjuryNov 25, 2019Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A RIGHT HIP REVISION SURGERY DUE TO LENGTH DISCREPANCY, PERI-PROSTHETIC FRACTURE. HEAD AND SLEEVE EXCHANGED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9372003 ↗