BHR 74122546Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00885556071588), received between Nov 2, 2017 and Jul 1, 2025 — classified as 40 injuries.

The most frequently reported specific device problem is “Biocompatibility” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER UNDERGOING A BHRMH IN HIS LEFT HIP JOINT ON (B)(6) 2010, PATIENT EXPERIENCED PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY. THEY ENCOUNTER SMALL FLUID COLLECTION AND SOME ADVERSE SOFT TISSUE REACTION. THIS WAS DEBRIDED AND IRRIGATED. ABDUCTOR TENDONS WERE INTACT WITHOUT SIGNIFICANT INVOLVEMENT. THE FEMORAL AND ACETABULAR COMPONENTS WERE SOLID. STERILE DRESSING WAS APPLIED. POSTOPERATIVE SURGICAL CHECKLIST WAS ALSO PERFORMED. FINALLY, PATIENT WAS TRANSFERRED TO PACU IN GOOD CONDITION.

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 22371728 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THA SURGERY WAS PERFORMED IN AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION. TO ADDRESS THIS ADVERSE EVENT, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024, DURING WHICH A HEMI HEAD 46MM WAS REMOVED AND REPLACED WITH A TANDEM UNIPOLAR 46MM, WHILE RETAINING THE SHELL, R3 LINER AND STEM. IT WAS MENTIONED THAT THE PATIENT WAS IN BAD SHAPE FOR UNSPECIFIED REASONS. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20262832 ↗
• InjuryMay 28, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT BHR-THA ON (B)(6) 2008 DUE TO DEGENERATIVE OSTEOARTHRITIS, THE PATIENT EXPERIENCED METALLOSIS ALONG WITH FEMORAL NECK OSTEOLYSIS. THIS EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE MODULAR HEAD AND SLEEVE WERE REMOVED. A 28MM OXINIUM FEMORAL HEAD AND A 28MMX46MM DUAL MOBILITY BEARING WERE PLACED IN EXCHANGE. EVEN THOUGH THERE WAS EVIDENCE OF OSTEOLYSIS ALONG THE ANTERIOR MARGIN OF THE ACETABULUM, THE CUP WAS RETAINED. THIS AREA WAS DEBRIDED WITHOUT COMPROMISING IMPLANT FIXATION AND THE ANTERIOR ACETABULAR WALL WAS BONE-GRAFTED. PATIENT WAS LATER TRANSFERRED TO THE PACU IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 19406429 ↗
• InjuryMay 23, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT BHR-THA ON (B)(6) 2008, THE PATIENT LATER EXPERIENCED SEVERE PAIN, LIMITING ADLS AND SLEEP, AND WERE DIAGNOSED WITH METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO CONVERT INTO A BIRMINGHAM DUAL MOBILITY HIP. A ONE DAY POST-OP VISIT REVEALED THE PATIENT SCAR HAD NO ERYTHEMA OR SWELLING, THE PATIENT HAD A NORMAL GAIT AND NO PAIN REPRODUCED WITH GENTLE IR/ER, FLEXION OR EXTENSION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19382357 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT HIP PRIMARY BHR THR PERFORMED ON (B)(6) 2011, THE PLAINTIFF SUFFERED FROM HIP PAIN IN THE LEFT HIP AND WAS PRESCRIBED WITH COUNTER ANTI-INFLAMMATORY. THIS ISSUE WAS THEN RESOLVED VIA A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2022. BLOOD TESTS FROM (B)(6) 2018 SHOWED HIGH METAL ION LEVELS. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; High metal ion levels

  MAUDE report 16957842 ↗
• InjuryMay 18, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED ON THE (B)(6) 2009, THE PATIENT PRESENTED CLIMBING LEVELS OF METAL IONS AND MIR CONFIRMED PSEUDOTUMORS. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022. DURING THIS PROCEDURE, THE FEMORAL HEAD AND SLEEVE WERE EXPLANTED, CLEAR TRUNNIONOSIS WAS FOUND. COMPETITORS DEVICES WERE IMPLANTED INSTEAD. THE PATIENT WAS IN STABLE CONDITION

  Patient problems: Infiltration into Tissue

  MAUDE report 16957264 ↗
• InjuryMar 18, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TOTAL RIGHT HIP ARTHROPLASTY USING A BHR SYSTEM WITH CORAIL STEM ON (B)(6) 2010 DUE TO ARTHROSIS, THE PLAINTIFF STARTED TO EXPERIENCE PAIN IN THE OPERATED HIP. THIS EVENT WAS SOLVED VIA REVISION SURGERY ON (B)(6) 2022, IN WHICH NECROTIC TISSUE AND DARK FLUID INDICATIVE OF AN ADVERSE LOCAL TISSUE REACTION SECONDARY TO METAL WEAR AND/OR CORROSION WAS NOTED. ALL THE COMPONENTS OF THE PRIMARY SURGERY WERE EXPLANTED AND REPLACED WITH A COMPETITOR'S SYSTEM. AFTER THE PROCEDURE, THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TAKEN TO THE POST ANESTHESIA CARE UNIT (PACU) IN STABLE CONDITION.

  Patient problems: Metal Related Pathology; Necrosis; Pain

  MAUDE report 16569498 ↗
• InjuryNov 12, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PRIMARY R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT HIP ON (B)(6) 2010, THE PATIENT EXPERIENCED PAIN AND ELEVATED COBALT LEVELS IN BLOOD. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO ADDRESS BOTH SYMPTOMS. DURING THIS PROCEDURE, THE MODULAR HEAD, THE CHROME-COBALT LINER AND THE ACETABULAR CUP WERE EXPLANTED AND REPLACED WITH A COMPETITOR¿S ACETABULAR SYSTEM AND A SMITH AND NEPHEW FEMORAL METALLIC HEAD. AS PART OF THE INTRAOPERATIVE FINDINGS, NO SIGNS OF METALLOSIS WERE SEEN AS WELL AS NO SIGNIFICANT SOFT TISSUE DESTRUCTION OF THE MUSCULATURE WAS NOTED UPON ENTERING THE CAPSULE. THE MODULAR HEAD WAS REMOVED AND NOTED TO HAVE A SMALL AMOUNT OF TRUNNIONOSIS WITHOUT DAMAGE TO THE STEM. ALTHOUGH A PREOPERATIVE BONE SCAN SUGGESTED THAT THE ACETABULAR COMPONENT WAS LOOSE, INTRAOPERATIVELY IT WAS DENOTED THAT THIS COMPONENT SHOWED GOOD BONY INGROWTH. THE PATIENT WAS AWOKEN FORM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

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

  MAUDE report 15785907 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING PROCEDURE, PATIENT WAS ENTERED TO HAVE REVISION SURGERY. IT IS UNKNOWN WHAT WAS THE ADVERSE EVENT THE PATIENT EXPERIENCED. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE AN UNKNOWN BIRMINGHAM HIP RESURFACING (BHR) HEAD. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15341547 ↗
• InjuryJun 10, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT SUSTAINED UNBEARABLE PAIN AND METALLOSIS. IT IS UNKNOWN IF THE PATIENT HAS ALREADY UNDERGONE SURGICAL INTERVENTION TO RESOLVE THESE SYMPTOMS, OR ANY OTHER MEASURES TAKEN TO TREAT THIS ADVERSE EVENT. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Infiltration into Tissue; Metal Related Pathology; Osteolysis

  MAUDE report 14655048 ↗
• InjuryMay 26, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON THE (B)(6) 2010, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 DUE TO HIGH METAL IONS LEVEL TO TREAT THIS ADVERSE EVENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Infiltration into Tissue; Pain

  MAUDE report 14519515 ↗
• InjuryMay 19, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR-THA WAS PERFORMED ON (B)(6) 2010 DUE TO DEGENERATIVE ARTHRITIS, THE PATIENT EXPERIENCED INCREASING COBALT AND CHROMIUM LEVELS. AN MRI SHOWED FLUID COLLECTION WITH SYNOVIAL THICKENING, CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION. THIS ADVERSE EVENT WAS TREATED WITH A LEFT REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Infiltration into Tissue; Synovitis

  MAUDE report 14438445 ↗
• InjuryApr 7, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT, AFTER A BHR THA ON (B)(6) 2008 DUE TO DEGENERATIVE ARTHRITIS AND LEG LENGTH INEQUALITY OF LEFT LOWER EXTREMITY. PLAINTIFF EXPERIENCES ADVERSE LOCAL TISSUE REACTION TO METAL. PLAINTIFF UNDERWENT REVISION SURGERY ON LEFT HIP ON (B)(6) WHERE A FLUID-FILLED CAVITY EXTENDED ALONG GREATER TROCHANTER, A MILD EROSION OF THE INFERIOR ABDUCTOR AND CONSIDERABLE TAPER CORROSION BETWEEN THE SLEEVE AND THE TAPER OF THE STEM WAS NOTICED. A SUBTOTAL SYNOVECTOMY WAS REQUIRED. IT IS UNKNOWN THE STATUS OF THE PATIENT.

  Patient problems: Metal Related Pathology

  MAUDE report 14047374 ↗
• InjuryApr 5, 2022Biocompatibility; Biocompatibility

  *US LEGAL MDL* IT WAS REPORTED THAT, AFTER PRIMARY RIGHT BHR THA WAS PERFORMED ON (B)(6) 2010 DUE TO ADVANCED ARTHRITIS, THE PATIENT EXPERIENCED METALLOSIS AND TRUNNIONOSIS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Erosion; Metal Related Pathology

  MAUDE report 14007568 ↗
• InjuryApr 4, 2022Biocompatibility; Biocompatibility

  US LEGAL MDL: IT WAS REPORTED THAT, AFTER A BHR-LEFT THA WAS PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED METALLOSIS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, IN WHICH A BLACK MATERIAL WAS FOUND BEHIND THE FEMORAL HEAD. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 13996029 ↗
• InjuryMar 23, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT, AFTER A BHR-THA IN (B)(6) 2010, PLAINTIFF PRESENTED METALLOSIS, FLUID IN THE HIP JOINT, PSEUDOTUMOR, ADVERSE LOCAL TISSUE DESTRUCTION, BLACK SYNOVITIS, AND CORROSION. PLAINTIFF UNDERWENT REVISION SURGERY ON UNKNOWN DATE. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Muscle Weakness/Atrophy; Numbness

  MAUDE report 13864487 ↗
• InjuryMar 17, 2022Biocompatibility; Biocompatibility

  *US LEGAL* IT WAS REPORTED THAT, AFTER A BHR-THA ON THE RIGHT HIP ON (B)(6) 2008 DUE TO OSTEOARTHRITIS, THE PLAINTIFF BEGAN EXPERIENCING PAIN AND ELEVATED METAL LEVELS. PLAINTIFF UNDERWENT REVISION SURGERY ON HIS RIGHT HIP ON (B)(6) 2018, WHERE SOME SYNOVIAL DEBRIS WERE NOTED. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 13794615 ↗
• InjuryDec 28, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A FIRST RIGHT HIP REVISION SURGERY PERFORMED ON (B)(6) 2009 (COVERED IN CASE-(B)(4)), THE PATIENT HAD A RIGHT HIP FAILURE. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ISSUE. DURING THE REVISION, SIGNIFICANT METALLOSIS WAS FOUND IN THE HIP. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 13094460 ↗
• InjuryNov 24, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR THA ON (B)(6) 2009 DUE TO DEGENERATIVE ARTHRITIS, PLAINTIFF HAS EXPERIENCE PAIN AND WAS DIAGNOSED WITH GLUTEUS MINIMUMS TENDON TEAR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHEN IT WAS FOUND SOME METALLIC STAINING ON THE MORSE TAPER AND ON THE FEMORAL HEAD THEREFORE THE HEMI HEAD 46MM WAS EXPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 12871021 ↗
• InjuryOct 15, 2021Biocompatibility; Biocompatibility

  US LEGAL MDL. IT WAS REPORTED THAT AFTER A LEFT R3-THA CONSTRUCT WAS IMPLANTED ON (B)(6)2018, PLAINTIFF EXPERIENCED OSTEOLYSIS WITH LOOSENING ACETABULAR COMPONENT, PSEUDOTUMOR AND ELEVATED COBALT AND CHROMIUM LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY LARGE AMOUNT OF CLOUDY STRAW-COLORED JOINT FLUID EMANATED FROM THE INCISION, THE TRUNNION WAS INSPECTED AND NOTED TO DEMONSTRATE BLACK METALLOSIS AND OSTEOLYSIS NEAR THE ACETABULAR COMPONENT AND FEMORAL COMPONENT WAS NOTICED. THE CUP, HEAD, LINER, AND SLEEVE WERE EXPLANTED AND REPLACE. THE STEM WAS WELL FIXED, SO IT WAS CONSERVED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 12639172 ↗
• InjuryMay 27, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR THA CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED PAIN, A FRACTURE ON THE GREATER TROCHANTER, OSTEOLYSIS WITH VERY HIGH COBALT LEVELS IN BLOOD AND TRUNNIONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY, A DRAB OLIVE-COLORED FLUID EGRESSED FROM THE JOINT. A SAMPLE WAS EVALUATED, INDICATING THE PRESENCE OF AN INFECTION. CORROSION WAS FOUND IN THE UNION BETWEEN THE FEMORAL HEAD AND THE SLEEVE, AS WELL AS ON THE STEM TRUNNION. EVEN THOUGH OSTEOLYSIS WAS FOUND AROUND THE FEMORAL AND ACETABULAR REGIONS, THE CUP AND THE STEM WERE DETERMINED TO BE WELL FIXED AND WERE NOT EXPLANTED. THE MODULAR FEMORAL HEAD AND THE MODULAR SLEEVE WERE REPLACED WITH AN OXINIUM HEAD WITH A POLY LINER TO CONSTRUCT A DUAL MOBILITY CONSTRUCT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s); Hip Fracture; Metal Related Pathology; Osteolysis; Pain; Unspecified Infection

  MAUDE report 11898181 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MEDICALLY INDICATED REVISION OF THE BHR-THA HYBRID SYSTEM RIGHT HIP ON (B)(6) 2019 DUE TO PAIN, LIMITED MOBILITY AND ELEVATED ION LEVELS. AMONG THE INTRAOPERATIVE FINDINGS THERE WAS DARK BROWN, DARK GRAY FLUID, EVIDENCE OF METALLOSIS AND CORROSION BETWEEN THE FEMORAL HEAD AND THE TRUNNION. THE PATIENT OUTCOME IS UNKNOWN.

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

  MAUDE report 11708253 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL - IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A MEDICALLY INDICATED REVISION OF THE BHR-THA RIGHT HIP ON (B)(6) 2020 DUE TO RECURRENT DISLOCATIONS AND METALLOSIS. AMONG THE INTRAOPERATIVE FINDINGS THERE WAS A SEVERE METALLOSIS WITH A SOFT TISSUE REACTION, PSEUDOTUMOR AND SEVERE ACETABULAR BONE LOSS. THE STEM WAS RETAINED AND A NEW S&N OXINIUM HEAD WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 11574595 ↗
• InjuryMar 15, 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 PATIENTS RIGHT HIP ON (B)(6) 2019 DUE TO A PAINFUL METAL-ON-METAL RIGHT TOTAL HIP REPLACEMENT WITH A LARGE PSEUDOTUMOR, THERE WAS A SIGNIFICANT AMOUNT OF PERIARTICULAR NECROSIS OF THE SOFT TISSUE WITH APPROXIMATELY 50-75% COMPROMISE OF THE ABDUCTOR MUSCLES. THE CUP AND THE STEM WERE RETAINED.

  Patient problems: Metal Related Pathology; Necrosis; Pain

  MAUDE report 11489837 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL MDL* IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT FOR A BHR RIGHT HIP ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED DUE TO PAIN IN THE RIGHT HIP SECONDARY TO A SUSPECTED REACTION TO THE METAL-ON-METAL ARTICULAR BEARING SURFACE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11408903 ↗