BHR 74122544Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556070994), received between Jul 10, 2018 and Oct 8, 2025 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING A BHR-THA ON (B)(6) 2012, THE PATIENT EXPERIENCED HIP PAIN THAT PROGRESSIVELY GOT WORSE, WITH A PAINFUL CLICKING SENSATION. LABORATORY TESTS SHOWED ELEVATED CHROMIUM AND COBALT LEVELS. ALSO, X-RAYS HAVE SHOWN SOME BONE LOSS. THEREFORE, ON 0(B)(6) 2025, A REVISION SURGERY WAS PERFORMED DUE TO THE MECHANICAL COMPLICATIONS AND THE METALOSIS WITH CHRONIC INFLAMMATION FROM METAL-ON-METAL. DURING THIS REVISION SURGERY, THE SYSTEM WAS CONVERTED TO DUAL MOBILITY HIP SYSTEM, SO THE ACETABULAR CUP HAP SIZE 44/50 AND THE BHR MODULAR HEAD 44MM WERE EXPLANTED. OSTEOLYSIS WAS FOUND IN THE POSTERIOR ASPECT OF THE FEMUR, AS WELL AS THE ANTERIOR JUNCTION WITH THE PUBIC RAMI. A SYNOVECTOMY OF THE STAINED METALLOSIS SYNOVIUM ALL AROUND THE HIP WITH SHARP DISSECTION AND CAUTERY FOR HEMOSTASIS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM, HAVING TOLERATED THE PROCEDURE WELL.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 23245538 ↗
• InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A R3-THA WAS PERFORMED ON (B)(6) 2010, THE PATIENT BENT FORWARD AND EXPERIENCED DISLOCATION OF THEIR HIP, THEY HAD TO ATTEND THE EMERGENCY ROOM ON (B)(6) 2023, AND WERE TREATED VIA A MANUEL REDUCTION. PATIENT WAS DISCHARGED IN STABLE CONDITION. FURTHER COMPLICATIONS RELATED TO THIS EVENT WERE NOT REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19459832 ↗
• InjuryNov 21, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S LEFT HIP ON (B)(6) 2011, THE PATIENT EXPERIENCED LOCAL SIGNS OF METALLOSIS, ELEVATED METAL ION LEVELS IN BLOOD AND PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A R3 44MM ID US COCR LNR 56MM AND A HEMI HEAD44MM WERE EXPLANTED AND REPLACED WITH AN OXINIUM HEAD AND A XLPE LINER. INTRAOPERATIVELY, THE SOFT TISSUES SHOW SIGNS OF METALLOSIS AND TRUNNIONOSIS. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Metal Related Pathology

  MAUDE report 15839260 ↗
• InjuryNov 12, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PRIMARY R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S LEFT HIP ON (B)(6) 2011, THE PATIENT HAS SUSTAINED LEFT HIP PAIN AND ELEVATED COBALT ION LEVELS IN BLOOD. A PREVIOUS SCAN HAD REVEALED THE POSSIBILITY OF LOOSENING OF THE ACETABULAR COMPONENT ALTHOUGH THE PATIENT IS ASYMPTOMATIC. THERE IS NO CONFIRMATION OF A REVISION SURGERY OR ANY OTHER INTERVENTION FOR THE LEFT HIP SO FAR. ALTHOUGH THIS PATIENT UNDERWENT REVISION SURGERY OF THE RIGHT HIP COMPONENTS ON (B)(6) 2022 LISTING THE SAME SYMPTOMS AS PREOPERATIVE DIAGNOSIS, THE CONTRIBUTION OF THE LEFT HIP PROSTHESIS TO THE REPORTED ELEVATED COBALT LEVELS COULD NOT BE DISCARDED. THE PATIENT IS CURRENTLY UNDER CONTINUOUS OBSERVATION.

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

  MAUDE report 15785887 ↗
• InjuryJul 28, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, THE PLAINTIFF UNDERWENT A R3 TOTAL HIP ARTHROPLASTY (RIGHT HIP) ON (B)(6) 2010 DUE TO HIP DYSPLASIA. SEVER DEFORMITIES OF ACETABULUM AND PROXIMAL FEMUR WITH COMPLETE LOSS OF NORMAL ARTICULAR CARTILAGE AND A 30 MM LIMB LENGTH DISCREPANCY ON THE RIGHT SIDE. THE PATIENT, DUE TO HIS CONTINUED PAIN AND DISABILITY, DECIDED TO PROCEED WITH A REVISION SURGERY OF THE RIGHT HIP. IT WAS NOTICED OSTEOLYSIS ON X-RAY AND ON RADIOLOGICAL IMAGE A FAILURE OF THE THA WITH MOM ARTICULATION WITH ELEVATED METAL IONS. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 WHERE THE BHR HEMI-HEAD WAS EXPLANTED. INTRAOPERATIVELY, NECROTIC TISSUE WAS SEEN. AFTER THE PROCEDURE THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology; Unequal Limb Length

  MAUDE report 15127070 ↗
• InjuryJul 26, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING A RIGHT THA PROCEDURE ON (B)(6) 2009, THE PATIENT EXPERIENCED CHRONIC PAIN. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022, IN WHICH EVIDENCE OF METALLIC CORROSION WAS NOTICED AT THE HEAD-NECK JUNCTION. THERE WAS A CARBON-LIKE BLACK DEPOSITION ON THE FEMORAL NECK AND WITHIN THE FEMORAL HEAD. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15108038 ↗
• InjuryNov 9, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A RIGHT R3-THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2009, PLAINTIFF EXPERIENCED SEVERE PAIN, LIMITED MOBILITY, METALLOSIS, AND ELEVATED COBALT AND CHROMIUM LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY, THE FEMORAL HEAD AND LINER WERE REPLACED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.¿

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 12782902 ↗
• InjuryJan 22, 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 LEFT HIP ON (B)(6) 2018. THE PATIENT REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN, LIMITED MOBILITY, AND ELEVATED COBALT AND CHROMIUM LEVELS. AMONG THE INTRAOPERATIVE FINDINGS THERE WAS METAL DEBRIS AND ALTR/ALVAL REACTION AS A RESULT OF THE PREMATURE FAILURE OF THE DEVICE, ALONG WITH TRUNNIONOSIS, FLUID AND SOFT TISSUES WHICH LOOKED LIKE COOKED LIVER. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Osteopenia/ Osteoporosis; Pain

  MAUDE report 11214146 ↗
• InjuryDec 9, 2020Adverse 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'S RIGHT HIP ON (B)(6) 2017. THE REVISION SURGERY WAS PERFORMED DUE TO AN INCREASINGLY PAINFUL HIP; MOVABLE MASS; FAILED RIGHT REVISION TOTAL HIP REPLACEMENT WITH EXTENSIVE METALLOSIS. THE PATIENT OUTCOME IS UNKNOWN.

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

  MAUDE report 10975356 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN. LINER AND HEAD EXCHANGED.

  Patient problems: Injury

  MAUDE report 9580007 ↗
• InjuryNov 27, 2019Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED A LEFT HIP REVISION DUE TO SEVERE PAIN, SEVERE INSTABILITY, SEVERE DISCOVER, PSEUDOTUMOR FORMATION, METALLOSIS, ADVERSE LOCAL TISSUE REACTION, AND LIMITED MOBILITY.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; Pain; Reaction; Toxicity

  MAUDE report 9384303 ↗
• InjuryJan 8, 2019Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS.

  Patient problems: Pain; Test Result; Toxicity

  MAUDE report 8225723 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT LEFT HIP REVISION SURGERY OF THE HEMI HEAD AND MODULAR SLEEVE ONLY WAS PERFORMED DUE TO METALLOSIS AND ELEVATED COBALT AND CHROMIUM LEVELS.

  Patient problems: Injury; Toxicity

  MAUDE report 7673480 ↗