BHR 74122548Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885556071847), received between Feb 23, 2018 and May 15, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Biocompatibility” (12 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025Corroded; Biocompatibility; Corroded; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A BILATERAL METAL-ON-METAL R3 THA PERFORMED ON (B)(6) 2010, THE PATIENT PRESENTED IN (B)(6) 2024 WITH INCREASED LEFT AND RIGHT HIP PAIN, AS WELL AS MECHANICAL SYMPTOMS, AND ELEVATED COBALT/CHROMIUM ION LEVELS. MRI SHOWS EVIDENCE OF ARMD/ALTR, MORE PRONOUNCED ON THE LEFT. A REVISION SURGERY FOR THE LEFT HIP WAS PERFORMED ON (B)(6) 2024 DUE TO A FAILED LEFT TOTAL HIP ARTHROPLASTY WITH EVIDENCE OF ADVERSE REACTION TO METAL DEBRIS. A SMALL AMOUNT OF INFLAMMATORY FLUID WAS FOUND, BUT NO SIGNS OF INFECTION. NUMEROUS SAMPLES WERE SENT FOR CULTURE AND ALSO FOR PATHOLOGIC ANALYSIS TO EVALUATE FOR ADVERSE REACTION TO METAL DEBRIS. ABDUCTORS WERE INTACT AND NO EVIDENCE OF BONE LOSS. THE 48 MM HEAD AND METALLIC SLEEVE WERE REMOVED. IN THE FEMORAL HEAD THERE WAS A SIGNIFICANT AMOUNT OF INFLAMMATORY TISSUE WITHIN THE BASE, WITH SIGNIFICANT BLACK METALLIC STAINING, INDICATING SIGNIFICANT CORROSION PRODUCT. WITHIN THE BASE OF THE SLEEVE, THERE WAS ALSO SIGNIFICANT AMOUNT OF CORROSION PRODUCT. WHILE TRYING TO INSPECT THE STEM, A SMALL AMOUNT OF CORROSION PRODUCT WAS NOTICED ON THE TRUNNION. THE STEM WAS RETAINED AND CORROSION WAS CLEANED. THE LINE

  Patient problems: Cramp(s) /Muscle Spasm(s); High metal ion levels; Implant Pain; Inflammation; Metal Related Pathology; Pain

  MAUDE report 22023810 ↗
• InjuryDec 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A BILATERAL METAL ON METAL BHR THA PERFORMED ON (B)(6) 2010, A RIGHT REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO A BROKEN PROSTHESIS. IN THE SURGERY, A SIGNIFICANT AMOUNT OF ADVERSE LOCAL TISSUE REACTION WAS NOTED WITHIN THE CAPSULE. THE CAPSULE WAS NOTICED TO HAVE RELATIVELY THICKENED. THE FEMORAL HEAD WAS REMOVED. ACETABULUM, STEM AND SLEEVE APPEARED TO BE WELL FIXED IN APPROPRIATE ALIGNMENT, SO THEY WERE RETAINED. AN OR3O DM XLPE INSERT 28/48 AND AN OXINIUM FEM HD 12/14 28 MM 3 WERE IMPLANTED IN ORDER TO REPLACE THE REMOVED IMPLANT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 21047858 ↗
• InjuryDec 27, 2024Fracture; Biocompatibility; Fracture; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PATIENT UNDERWENT A BILATERAL METAL-ON-METAL BHR THA PERFORMED ON (6) (B)2010, SHE STARTED TO EXPERIENCE PAIN AROUND 2023 ALONG HER LEFT HIP. AN MRI DEMONSTRATED A SMALL LOCAL TISSUE REACTION AND A BROKEN INTERNAL LEFT HIP PROSTHESIS. IN ADDITION, A BLOOD TEST REVEALED AN ELEVATED COBALT-CHROMIUM LEVELS IN BLOOD. A REVISION SURGERY TO HER LEFT HIP WAS PERFORMED ON (B)(6) 2024, IN WHICH WAS NOTICED EVIDENCE OF OSTEOLYSIS IN THE INFERIOR ASPECT OF HER LEFT ACETABULUM. THERE WAS SOME SYNOVITIS NOTED AROUND THE CUP ACETABULAR COMPONENT, BUT THIS WAS NOTED TO BE WELL-FIXED. WITH SIGNIFICANT MANIPULATION THE LARGE FEMORAL HEAD WAS REMOVED FROM THE TRUNNION INTO 2 SEPARATE PIECES. INSIDE THE TRUNNION THERE WAS SOME BLACK DEBRIS CONSISTENT WITH TRUNNIONOSIS. A OXINIUM FEM HD 12/14 28MM -3 AND A OR3O DM XLPE INSERT 28/48 WERE IMPLANTED AND MADE AN EXCELLENT FIT AND MATCHING TO THE EXISTING CUP. ACETABULAR COMPONENT WAS WELL-POSITIONED AND DID NOT REQUIRE REVISION. THE HEAD AND SLEEVE WERE ALSO RETAINED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: High metal ion levels; Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 21031273 ↗
• InjuryMay 15, 2023Biocompatibility; Naturally Worn; Insufficient Device Problem Information; Biocompatibility; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER UNDERGOING TOTAL LEFT HIP REPLACEMENT ON (B)(6) 2009 DUE TO SEVERE PAIN AND ARTHRITIS, THE PATIENT PRESENTED METALLOSIS, ELEVATED METAL IONS IN BLOOD, AND MRI FINDINGS CONSISTENT WITH PSEUDOTUMOR. THIS COMPLICATION WAS TREATED BY PERFORMING A REVISION SURGERY WITH DEBRIDEMENT ON (B)(6) 2022, IN WHICH THE FEMORAL HEAD, SLEEVE AND LINER WERE EXCHANGED. A SYNOVIAL BIOPSY WAS CONDUCTED; HOWEVER, NO TEST RESULTS ARE AVAILABLE AT THIS TIME. DURING THIS SURGERY, SIGNIFICANT DAMAGE WAS OBSERVED ON THE PRIMARY FEMORAL HEAD AND METALLIC LINER. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM IN A STABLE CONDITION.

  Patient problems: High metal ion levels; Insufficient Information; Metal Related Pathology; Solid Tumor

  MAUDE report 16936513 ↗
• InjuryMay 10, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2011, THE PATIENT EXPERIENCED PAIN WITH ADVERSE LOCAL SOFT TISSUE REACTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO ADDRESS THIS COMPLICATION. DURING THIS PROCEDURE, THE HEMI HEAD WAS EXPLANTED AND REPLACED WITH SMITH & NEPHEW BACK-UP DEVICES. ACETABULAR CUP, MODULAR SLEEVE AND STEM WERE RETAINED. INTRAOPERATIVELY, A TRUNNIONOSIS NOTED ALONG THE INSIDE OF THE HEAD AND A SMALL PSEUDOTUMOR FORMATION AT THE INFERIOR ASPECT OF THE CUP WERE FOUND. THE PROCEDURE WENT UNEVENTFUL, AND THE PATIENT WAS TRANSFER TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Implant Pain; Metal Related Pathology

  MAUDE report 16903701 ↗
• InjuryMar 28, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A TOTAL HIP ARTHROPLASTY IN THE LEFT HIP WAS PERFORMED ON (B)(6) 2013 DUE TO ARTHRITIS, THE PLAINTIFF PRESENTED AN ADVERSE LOCAL TISSUE REACTION. THE ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022 WHERE THE FEMORAL HEAD AND HEAD SLEEVE WERE EXPLANTED. DURING THE SURGERY, A THOROUGH SYNOVECTOMY WAS DONE TO REMOVE THE ADVERSE LOCAL TISSUE REACTION. THE PLAINTIFF HAD QUITE A BIT OF BONE LOSS AROUND THE FEMORAL STEM MISSING THE MAJORITY OF HIS GREATER TROCHANTER. AT THE END OF THE SURGERY, THE PLAINTIFF WAS TAKEN TO RECOVERY IN STABLE CONDITION.

  Patient problems: Foreign Body Reaction

  MAUDE report 16632452 ↗
• InjuryFeb 14, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2022 DUE TO METALLOSIS, WEAKNESS AND ACUTE PAIN OF THE RIGHT HIP. DURING THE SURGERY, THE HIP CAPSULE WAS FOUND BLACK-STAINED. THE METALLIC FEMORAL HEAD, THE NECK, THE METAL LINER, AND THE FEMORAL STEM WERE EXPLANTED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY UNIT IN STABLE CONDITION. THE PRIMARY MOM RIGHT HIP SURGERY WAS PERFORMED ON (B)(6) 2010.

  Patient problems: Fatigue; Headache; Metal Related Pathology; Muscle Weakness/Atrophy; Tinnitus

  MAUDE report 16372688 ↗
• InjuryDec 21, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2010, THE PATIENT HAS BEEN EXPERIENCING SEVERE RIGHT HIP PAIN AND LIMITED AMBULATION WITH DECREASED RANGE OF MOTION. AFTER THIS PROCEDURE, SEVERAL RIGHT HIP RADIOGRAPHS HAVE BEEN TAKEN WHICH REVEAL AN OVERALL STABLE APPEARANCE WITHOUT SIGNIFICANT CHANGES, EVIDENCE OF LOOSENING OR PRESENCE OF FRACTURES. A CHROMIUM AND COBALT LEVELS IN BLOOD TEST CONDUCTED ON (B)(6) 2021 REVEALED CONCENTRATIONS BELOW 3 NG/ML FOR BOTH IONS. TO TREAT THE ONGOING RIGHT HIP PAIN, THE PATIENT UNDERWENT A FEMORAL AND OBTURATOR NERVE BLOCK PROCEDURE UNDER FLUOROSCOPIC GUIDANCE ON (B)(6)0. DURING THIS PROCEDURE, THE ARTICULAR BRANCH OF THE FEMORAL AND OBTURATOR NERVE WAS BLOCKED WITH 1 ML OF 0.25% BUPIVACAINE, RESPECTIVELY. IN ADDITION, ON (B)(6) 2021, THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION OF THE ARTICULAR BRANCH OF BOTH NERVES WITH THE SAME DIAGNOSIS OF PERSISTENT RIGHT HIP PAIN. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fall; Inadequate Pain Relief; Loss of Range of Motion; Metal Related Pathology; Osteolysis

  MAUDE report 16030237 ↗
• InjuryDec 16, 2022Degraded; Biocompatibility; Degraded; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY HIP REPLACEMENT ON THE LEFT HIP WITH BHR-THA IMPLANTS ON (B)(6) 2009. AFTER THIS PROCEDURE, THE PATIENT HAS SUSTAINED UNSPECIFIED TROUBLES WITH THE PROSTHESIS. HER LAB TEST RESULTS HAVE SHOWN ELEVATED CHROMIUM AND COBALT LEVELS SINCE (B)(6) 2017. ACCORDING TO A PHYSICAL THERAPY PROGRESS NOTE ON (B)(6) 2021, THE PATIENT DOES NOT PLAN TO HAVE SURGICAL INTERVENTION ON THE LEFT HIP PROSTHESIS UNLESS ABSOLUTELY NECESSARY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); High metal ion levels; Infiltration into Tissue; Metal Related Pathology; Pain

  MAUDE report 15997026 ↗
• InjuryMay 26, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A REVISION SURGERY OF THE RIGHT HIP DUE TO METALLOSIS, ON (B)(6) 2020. DURING PROCEDURE IT WAS FOUND A DISLOCATION OF LARGE MOM PROSTHETIC FEMORAL HEAD POSTERIORLY, SOFT TISSUE DESTRUCTION AND FIBROUS FIXATION OF THE CUP. THE PRIMARY RIGHT BHR THA SURGERY WAS PERFORMED ON (B)(6) 2010. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 14519617 ↗
• InjuryMay 23, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN AND ELEVATED METAL ION LEVELS INCLUDING 10 TIMES NORMAL COBALT LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETABULAR CUP HAP SIZE 48/54 AND HEMI HEAD 48MM WERE EXPLANTED AND REPLACED WITH AN OXINIUM FEMORAL HEAD AND A BIRMINGHAM DUAL MOBILITY LINER. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Arthralgia; Metal Related Pathology

  MAUDE report 14470585 ↗
• InjuryMay 19, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER PRIMARY LEFT HIP BHR RESURFACING SURGERY WAS PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN AND SUBLUXATION OF THE FEMORAL COMPONENT, FOR WHICH REVISION SURGERY WAS CONDUCTED ON (B)(6) 2012 (COVERED UNDER (B)(4)). SUBSEQUENTLY, THE PATIENT EXPERIENCED COBALT AND CHROMIUM TOXICITY, AS WELL AS ACETABULAR OSTEOLYSIS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2020. FROM ALL THE COMPONENTS, ONLY THE STEM WAS LEFT IN PLACE. THE SYSTEM WAS REPLACED TO A COMPETITOR´S THA. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 14436195 ↗
• InjuryNov 8, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  US LEGAL MDL - IT WAS REPORTED THAT AFTER A LEFT BHR THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2010, PLAINTIFF EXPERIENCED RISING COBALT CHROME LEVELS ON BLOOD AS WELL AS FLUID COLLECTION SHOWED ON MRI ON LEFT HIP. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY TISSUES HAD SOME METAL STAINING AND THERE WAS A SMALL AMOUNT OF CORROSION OF THE TRUNNION. FEMORAL HEAD WAS EXPLANTED. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Infiltration into Tissue; Metal Related Pathology

  MAUDE report 12773846 ↗
• InjuryNov 17, 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 ON THE LEFT HIP, THE PATIENT EXPERIENCED SEVERE PAIN, LIMITED MOBILITY, AND ELEVATED COBALT AND CHROMIUM LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO ADDRESS THIS EVENT. AMONG THE INTRA-OPERATIVE FINDINGS AND DIAGNOSES WERE METALLOSIS, AND SPECIFICALLY TRUNNIONOSIS AND CORROSION AT THE NECK-STEM JUNCTION, AS A RESULT OF THE PREMATURE FAILURE OF THE DEVICE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 10853531 ↗
• InjuryOct 13, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT A BHR REVISION SURGERY WAS PERFORMED ON (B)(6) 2020, DUE TO UNKNOWN REASONS. THE CUP, HEAD AND SLEEVE WERE EXPLANTED. IT IS UNKNOWN THE CURRENT STATE OF THE PATIENT.

  Patient problems: Injury

  MAUDE report 10671181 ↗
• InjuryApr 7, 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 REVISION SURGERY WAS PERFORMED DUE TO ELEVATED METAL IONS LEVELS.

  Patient problems: Injury; Test Result

  MAUDE report 9932406 ↗
• InjuryFeb 6, 2020Adverse 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 A LEFT HIP REVISION SURGERY DUE TO SEVERE LEG LENGTH DISCREPANCY, PAIN, ELEVATED TEST RESULTS.

  Patient problems: Injury; Pain; Test Result

  MAUDE report 9676497 ↗
• InjuryMay 28, 2019Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 8644784 ↗
• InjuryMar 1, 2019Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS. ALL COMPONENTS REMOVED.

  Patient problems: Tissue Damage; Toxicity

  MAUDE report 8381223 ↗
• InjuryMar 1, 2019Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO MECHANICAL COMPLICATIONS.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 8381151 ↗
• InjuryAug 28, 2018Material Disintegration; Fracture; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY FOR LEFT HIP DUE TO METAL DEBRIS, AND FEMORAL NECK FRACTURE. CUP REMAINED IN SITU AND FEMORAL HEAD WAS EXPLANTED. REPLACED WITH SYNERGY, 48 MM HEAD AND SLEEVE.

  Patient problems: Bone Fracture(s); Injury; No Code Available

  MAUDE report 7824794 ↗
• InjuryFeb 23, 2018Patient Device Interaction Problem; Material Integrity Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. SURGEON REPORTEDLY SUSPECTED ALVAL DUE TO HIGH METAL ION LEVELS.

  Patient problems: Test Result; Toxicity

  MAUDE report 7291581 ↗