BHR 74122550Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00885556071205), received between Oct 17, 2017 and Jun 24, 2025 — classified as 45 injuries.

The most frequently reported specific device problem is “Biocompatibility” (22 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT BHR-THA HAD BEEN PERFORMED ON (B)(6) 2008, PATIENT EXPERIENCED FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO METALLOSIS. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, THE SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY AND THE HEMI HEAD 50MM AND THE MODULAR SLEEVE WERE EXPLANTED. IN ADDITION, DURING PROCEDURE, THE HIP WAS ASPIRATED, AND 10 CC OF CLOUDY SYNOVIAL FLUID ENCOUNTERED, CONSISTENT WITH METALLOSIS. THE CAPSULE WAS MARKEDLY THICKENED, AND DISTORTED ANATOMY WAS ENCOUNTERED GIVEN PRIOR POSTERIOR APPROACH HIP REPLACEMENT WITH SUBSEQUENT METALLOSIS. THICKENED CAPSULE WAS DEBRIDED ON THE UNDERSURFACE. THE SUPERFICIAL CAPSULE WAS TAGGED AND RETRACTED SUPERIORLY. A EXOFIN DRESSING WAS APPLIED, FOLLOWED BY A STERILE DRESSING. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TAKEN TO THE PACU IN GOOD CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 22323198 ↗
• InjuryMay 15, 2025Biocompatibility; Noise, Audible; Biocompatibility; Noise, Audible

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A RIGHT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2011, DID VERY WELL POSTOPERATIVELY UNTIL ABOUT A YEAR AGO, SUBSEQUENT TO A LUMBAR ARTHRODESIS IN LATE 2023. PATIENT HAS BEEN SUFFERING OF PAIN IN THE RIGHT HIP, WITH CLICKING. HE WAS NOTED TO HAVE MODERATE ELEVATION OF HIS SERUM CHROMIUM AND COBALT IONS CHROMIUM 3.6, COBALT 6.4, WHICH WERE TRENDING UPWARD. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, THE DEEP CAPSULE WAS EXAMINED. THERE WAS SOME DISCOLORATION OF THE DEEP CAPSULE, BROWNISH GRAY, BUT NOT EXTENSIVE. ALL OF THE MUSCLE APPEARED TO BE HEALTHY. SMALL AREAS OF CAPSULE WERE EXCISED, WHICH ALLOWED THE HIP TO BE DISLOCATED, AND THE REMAINDER OF THE QUESTIONABLE CAPSULAR AREAS TO BE EXCISED. THIS WAS THEN SENT AS A SPECIMEN TO THE PATHOLOGIST FOR EXAMINATION IN THE CASE OF POSSIBLE METALLOSIS, STATUS POST METAL-ON-METAL HIP FROM 15 YEARS AGO, WITH RECENT MODEST ELEVATION IN SERUM IONS. UPON OPENING THE CAPSULE, THERE WAS A SMALL AMOUNT OF JOINT FLUID, SLIGHTLY BROWN, NOT PURULENT, WHICH WAS SENT FOR SURVEILLANCE AEROBIC AND ANAEROBIC CULTURES TO MICROBIOLOGY LAB. PORTION OF DENSE FIBROUS AND FATTY TISSUE, AND SYNOVIUM WITH R

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 22026753 ↗
• 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 RIGHT HIP WAS PERFORMED ON (B)(6) 2024 DUE TO A FAILED RIGHT 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 50 MM HEAD AND METALLIC SLEEVE WERE REMOVED. IN THE FEMORAL HEAD THERE WAS INFLAMMATORY TISSUE WITHIN THE BASE (BUT LESS THAN IN THE LEFT), WITH SIGNIFICANT BLACK METALLIC STAINING, INDICATING SIGNIFICANT 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 LINER WAS ALSO REMOVED AND INSPECTED, AND IT WAS NOTICED SIGNIFICANT CORROSION PRODU

  Patient problems: Cramp(s) /Muscle Spasm(s); Diarrhea; Dizziness; Headache; Metal Related Pathology; Pain; Vomiting

  MAUDE report 22024839 ↗
• InjuryMay 22, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PATIENT UNDERWENT A LEFT PRIMARY BHR-THA ON (B)(6) 2008. LATER HAD ONSET OF PAIN FOR SEVERAL YEARS; PATIENT WAS DIAGNOSED WITH METALLOSIS, AND BECAME FUNCTIONALLY DISABLING IN THE ACTIVITIES OF DAILY LIVING. MUSCULOSKELETAL ROS WAS POSITIVE FOR DECREASE RANGE OF MOTION, JOINT PAIN, JOINT SWELLING AND STIFF JOINTS. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH THE SHELL AND STEM WERE FOUND TO BE STABLE, SO THE HIP WAS CONVERTED INTO A BIRMINGHAM DUAL MOBILITY WITH AN OXINIUM FEMORAL HEAD. THE PATIENT WAS AWAKENED FROM ANESTHESIA AFTER SURGERY. NO OTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 19372523 ↗
• InjuryOct 17, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR THA SURGERY OF THE LEFT HIP PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED METALLOSIS FROM A METAL-ON-METAL PROSTHESIS WITH AN ELEVATED SERUM COBALT / CHROMIUM LEVELS AS WELL AS A PSEUDOTUMOR ON MRI. THIS CONDITION WAS TREATED BY PERFORMING A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2023, DURING WHICH THE MODULAR HEAD AND SLEEVE WERE EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW DUAL MOBILITY INSERT AND AN OXINIUM FEMORAL HEAD. AFTER THE SURGERY, THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 17953075 ↗
• InjurySep 3, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER THE PLAINTIFF UNDERWENT A BHR RIGHT THA SURGERY ON (B)(6) 2008, HE EXPERIENCED IMPLANT PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IN WHICH THE SURGEON FOUND THAT THERE WAS AN EXTENSIVE OSTEOLYSIS OF THE GREATER TROCHANTER WITH A RENT IN THE ANTERIOR ABDUCTORS. IT WAS NOTICED THAT THE HIP JOINT HAD A CLOUDY MILK CONSISTENT WITH METALLOSIS. ALSO, THERE WAS EXTENSIVE DAMAGE OF THE GLUTEUS MEDIUS AND ABDUCTORS FROM THE OSTEOLYSIS. THE ANTERIOR STRUCTURES WERE CERTAINLY QUITE NECROTIC. IT WAS FOUND THAT THE SOURCE OF THE METALLOSIS WAS THE TRUNNION. THE MODULAR HEAD AND SLEEVE WERE EXPLANTED AND REPLACED FOR A BHR DUAL MOBILITY LINER AND AN OXINIUM HEAD. THE FEMORAL NECK WAS OTHERWISE IN GOOD CONDITION AND NO EROSION OF THE PERIPHERY OF THE ACETABULAR COMPONENT WAS FOUND; THEREFORE, THE ACETABULAR AND FEMORAL COMPONENT WERE NOT EXPLANTED. THE PROCEDURE ENDED WELL BUT THE PATIENT HAS A HIGH RISK OF DISLOCATION DUE TO THE EXTENSIVE NECROSIS OF HIS ABDUCTORS.

  Patient problems: Implant Pain; Metal Related Pathology; Osteolysis

  MAUDE report 17675078 ↗
• InjuryMay 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A LEFT THA SURGERY WAS PERFORMED ON THE (B)(6) 2009, THE PATIENT PRESENTED PERSISTENT PAIN WITH ELEVATED METAL IONS. X-RAYS SHOWED FINDINGS OF OSTEOLYSIS, AND THE PATIENT WAS SCHEDULED FOR REVISION SURGERY FOR THE (B)(6) 2022. DURING THE PROCEDURE, CORROSION OF THE TRUNNION OF THE FEMORAL COMPONENT WITH METAL DEBRIS THROUGHOUT THE HIP JOINT WAS FOUND. A COMBINATION OF SMITH AND NEPHEW WITH COMPETITOR DEVICES WERE IMPLANTED IN EXCHANGE. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Arthralgia; Insufficient Information; Osteolysis

  MAUDE report 16935888 ↗
• InjuryDec 14, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT HIP BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2008, THE PATIENT EXPERIENCED ELEVATED COBALT AND CHROMIUM ION LEVELS IN BLOOD. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE MODULAR FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH AN OXINIUM HEAD AND A DUAL-MOBILITY POLYETHYLENE LINER. THE ACETABULAR AND FEMORAL COMPONENT WERE LEFT IN SITU. INTRAOPERATIVELY, A DARK COLORED DEBRIS AT THE TAPER JUNCTION WAS NOTICED UPON REMOVING THE MODULAR HEAD AND SLEEVE, ALTHOUGH THE TRUNNION WAS INTACT. THE PATIENT TOLERATED WELL THE PROCEDURE AND WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 15978910 ↗
• InjuryAug 17, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT RIGHT METAL ON METAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 DUE TO PERTHES DISEASE. THE PATIENT STARTED TO EXPERIENCE SYSTEMIC SYMPTOMS AND ELEVATED METAL IONS LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO RESOLVE THESE EVENTS. DURING THE PROCEDURE, THE FEMORAL HEAD AND THE SLEEVE WERE EXPLANTED. THE CURRENT STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 15244163 ↗
• InjuryJun 4, 2022Biocompatibility; Biocompatibility

  *US LEGAL MDL* IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2008. THE PATIENT EXPERIENCED MECHANICAL LOOSENING OF THE INTERNAL RIGHT HIP PROSTHETIC JOINT, ADVERSE LOCAL TISSUE REACTION WITH METALLOSIS, PSEUDO CAPSULE AND METAL OASIS AT THE TRUNNION WITH CHRONIC RIGHT HIP PAIN. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. THE IDENTITY OF THE EXPLANTED DEVICES AND THE PROSTHESIS IMPLANTED IN EXCHANGE IS YET TO BE CONFIRMED. THE PATIENT¿S OUTCOME IS UNKNOWN.

  Patient problems: Joint Laxity; Metal Related Pathology

  MAUDE report 14599399 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CONVERSION FROM BHR TO BHR-THA HAD BEEN PERFORMED IN OR AROUND 2011, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS THAT MADE NECESSARY AN ADDITIONAL INTERVENTION ON (B)(6) 2022. DURING THIS REVISION SURGERY, THE 50MM BHR HEMI HEAD AND THE 56/50 MM BHR ACETABULAR CUP WERE EXPLANTED AND REPLACED WITH AN OXINIUM FEMORAL HEAD AND A COMPETITOR¿S ACETABULAR SHELL AND PLASTIC LINER. THE PATIENT¿S OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14595312 ↗
• InjuryMay 30, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER RIGHT BHR-THA SURGERY WAS PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED INCREASED PAIN, SWELLING, ADVERSE LOCAL TISSUE REACTION, ELEVATED METAL IONS LEVELS AND PSEUDOTUMOR ANTERIORLY. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. DURING THE SURGERY, THE HEMI HEAD AND THE MODULAR SLEEVE WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inflammation; Metal Related Pathology; Pain; Solid Tumor

  MAUDE report 14545086 ↗
• InjuryMay 24, 2022Biocompatibility; Biocompatibility

  US LEGAL: IT WAS REPORTED THAT, AFTER RIGHT BHR-THA CONVERSION WAS PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED METALLOSIS, ELEVATED METAL ION LEVELS AND PAIN IN THE RIGHT HIP. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE BHR HEMI HEAD WAS EXPLANTED AND REPLACED WITH AN OXINIUM 28MM FEMORAL HEAD AND DUAL MOBILITY LINER FROM SMITH AND NEPHEW. INTRAOPERATIVELY, A SMALL AMOUNT OF METAL DEBRIS ALONG THE MOST PROXIMAL AND SIDE ASPECT OF THE TRUNNION WAS NOTED. THE PATIENT¿S OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14487412 ↗
• InjuryMay 21, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, LEFT BHR-THA WAS PERFORMED ON (B)(6) 2007 DUE TO ARTHRITIS, THE PATIENT EXPERIENCED PAIN AND SIGNIFICANT HIGH COBALT AND CHROMIUM IONS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, IN WHICH TRUNIONOSIS AND SMALL PSEUDOTUMOR FORMATION WERE OBSERVED. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14465914 ↗
• InjuryMay 19, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT BHR-THA WAS PERFORMED ON (B)(6) 2009 DUE TO HIP ARTHROSIS, THE PATIENT EXPERIENCED ELEVATED METAL ION LEVELS, ESR AND CRP. ULTRASOUND SHOWED FLUID COLLECTION ON LEFT HIP. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2014. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14436258 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL. 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 UNSPECIFIED SYMPTOMS THAT WERE ADDRESSED WITH A PROSTHESIS REPLACEMENT. A REVISION SURGERY WAS PERFORMED ON (B)(6)2019; DURING THIS PROCEDURE THE HEMI HEAD 50MM WAS EXPLANTED AND REPLACED WITH AN OXINIUM FEMORAL HEAD WITH A -3 SETTING 12/14 TAPER AND A DUAL MOBILITY LINER. THE PATIENT¿S OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14047444 ↗
• InjuryMar 24, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT IS REPORTED THAT, AFTER BHR-THA ON (B)(6) 2010, THE PLAINTIFF HAS SUFFERED FROM METALLOSIS AND MULTI-SYSTEM REACTION WHICH HAS CAUSED HIM PAIN AND MENTAL ANGUISH. PLAINTIFF UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Distress; High metal ion levels; Insufficient Information; Metal Related Pathology; Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 13896797 ↗
• InjuryDec 28, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT BHR THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2009 DUE TO AVASCULAR NECROSIS, THE PLAINTIFF EXPERIENCED ELEVATED METAL ION LEVELS, TRUNNIONOSIS, RIGHT HIP PAIN AND RIGHT LEG LENGTH DISCREPANCY. PATIENT UNDERWENT A REVISION SURGERY ON THE RIGHT HIP ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS, WHERE THE HEAD WAS EXPLANTED AND REPLACED WITH AN OXINIUM FEMORAL HEAD AND A DUAL MOBILITY LINER. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology; Unequal Limb Length

  MAUDE report 13101404 ↗
• InjuryDec 28, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER LEFT BHR THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2010, THE PLAINTIFF EXPERIENCED METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THE SURGERY, SIGNIFICANT OSTEOLYSIS WAS NOTED AROUND THE CUP, AS WELL AS LARGE COLLECTION OF BROWN FLUID. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 13101087 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT BHR-THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2008, PLAINTIFF EXPERIENCED CYST FLUID COLLECTION, ABSCESS, SWELLING, ERYTHEMA, POSSIBLE INFECTION, METALLOSIS, PAIN AND ELEVATED COBALT AND CHROMIUM IONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY GRANULOMATOUS CHANGES, CLOUDY FLUID, AND SYNOVITIS WERE NOTED. ALSO, TRUNNION GNOSIS WITH BLACK STAINING OF THE TRUNNION WAS NOTED. THE WHOLE BHR-THA CONSTRUCT WAS REMOVED AND REPLACE WITH NEW COMPONENTS. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 12788659 ↗
• InjuryNov 9, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PRIMARY R3-THA METAL ON METAL CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S RIGHT HIP ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED ELEVATED COBALT LEVELS IN SERUM, METALLOSIS AND PSEUDOTUMOR FORMATION IN THE POSTERIOR ASPECT OF THE HIP. INTRAOPERATIVELY, A BLACKENED MATERIAL WAS NOTED AROUND THE TRUNNION CONSISTENT WITH TRUNNIONOSIS. DURING THIS PROCEDURE, THE CO-CR MODULAR HEAD, THE CO-CR ACETABULAR LINER AND THE 25MM SPHERICAL HEAD SCREW WERE EXPLANTED AND REPLACED WITH A OXINIUM -4 FEMORAL HEAD AND A POLYETHYLENE LINER. THE PLAINTIFF WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Infiltration into Tissue

  MAUDE report 12778476 ↗
• InjuryAug 9, 2021Biocompatibility; Biocompatibility

  *US LEGAL* BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A METAL ON METAL CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF'S LEFT HIP ON (B)(6) 2012, THE PLAINTIFF EXPERIENCED PAIN AND METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 12294877 ↗
• InjuryJun 1, 2021Biocompatibility; Biocompatibility

  *US LEGAL MDL* IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF'S LEFT HIP ON AN UNKNOWN DATE, THE PLAINTIFF EXPERIENCED METALLOSIS AND INCREASED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF OUTCOME IS UNKNOWN.

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

  MAUDE report 11913842 ↗
• InjuryMay 12, 2021Biocompatibility; Biocompatibility

  *US LEGAL MDL* IT WAS REPORTED THAT, AFTER A BHR THA RIGHT HIP CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2008, THE PLAINTIFF EXPERIENCED A LOCAL TISSUE REACTION, ELEVATED METAL IONS, AND POSSIBLE FEMORAL OSTEOLYSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THESE ADVERSE EVENTS. DURING SURGERY, DARK FLUID AND BLACK STAINED TISSUE WAS FOUND. A LINEAR RENT IN THE PERITROCHANTERIC BONE LEADING TO A CAVITARY DEFECT ALONG THE INSIDE OF THE GREATER TROCHANTER WAS ALSO FOUND. A COMPLETE SYNOVECTOMY, PROXIMAL BONE GRAFTING AND ABDUCTOR REPAIR WERE PERFORMED. THE HEMI HEAD AND THE HEAD SLEEVE WERE EXPLANTED FROM THE PLAINTIFF. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 11814144 ↗
• InjuryMay 11, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR THA LEFT HIP CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED AN ELEVATED ION LEVELS AND ADVERSE LOCAL TISSUE REACTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THESE ADVERSE EVENTS. DURING SURGERY, IT WAS NOTICED THAT THE EXTERNAL ROTATORS AS WELL AS POSTERIOR CAPSULE WERE ATROPHIED AND YELLOWED. THERE WAS CLEARLY TRUNNION CORROSION WITH BLACKENED MATERIAL. THE CUP, THE HEMI HEAD AND THE METAL SLEEVE WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 11810153 ↗