BIRMINGHAM HIP RESURFACING (BHR) 74120158Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 03596010502605), received between May 22, 2017 and May 9, 2025 — classified as 60 injuries.

The most frequently reported specific device problem is “Biocompatibility” (20 reports).

29 other recalls cover devices cleared under the same FDA submission (P040033); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2011, THE PATIENT SINCE (B)(6) OF 2023 HAS BEEN SYMPTOMATIC. HE FELT POPPING AND SOMETHING SLIPPED INAPPROPRIATELY IN THE HIP. FURTHER EVALUATION REVEALED HIGH SERUM METAL ION LEVELS AS WELL AS RETROACETABULAR OSTEOLYSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE HIP CAPSULE WAS OPENED AND BLACK FLUID PRESENTED ITSELF. THE STEM WAS WELL-POSITIONED AND WELL OSSEOINTEGRATED. THERE WAS NO BLACK DISCOLORATION OF THE TRUNNION BUT THE VERY TIP OF THE TRUNNION HAD A UNUSUAL METAL RIDGE. IT WAS NOT UNSTABLE. THE SURGEON DECIDED TO LEAVE THE STEM IN PLACE. THE ACETABULAR COMPONENT HAD LITTLE BONE INGROWTH. THERE WAS EXTENSIVE BLACK DISCOLORATION OF THE SYNOVIUM WHICH WAS DEBRIDED. THERE WERE 2 MAJOR CAVITIES AND THE ACETABULUM FILLED WITH BLACK MATERIAL. A COMPREHENSIVE DEBRIDEMENT OF FASCIA AND SYNOVIUM WAS PERFORMED TO REMOVE THE VAST MAJORITY OF THE BLACK DISCOLORATION. THE 2 DISTINCT CAVITIES AND THE ACETABULAR BONE WERE DEBRIDED WITH CURETTES AND LATER FILLED WITH CANCELLOUS BONE CHIPS. THE ACETABULAR AND HEAD COMPONENTS WERE REMOVED AND REPLACED FOR COMPETITOR (STRYKER) ACETABU

  Patient problems: Arthritis; Metal Related Pathology; Pain

  MAUDE report 21993782 ↗
• InjuryMay 9, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR IN HIS LEFT HIP JOINT ON (B)(6) 2013, PATIENT EXPERIENCED COBALT AND CHROMIUM ELEVATED LEVELS ALONG WITH A LARGE PSEUDOTUMOR MASS ABUTTING THE FEMORAL NERVE. CAUSING ALSO METALLOSIS IN HIS LEFT HIP. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2023, DURING WHICH, SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY. DURING PROCEDURE, WHEN THEY COMPLETED THEIR CAPSULOTOMY, THEY LIBERATED AT LEAST 400 ML OF GRAY OPAQUE FLUID. IN ADDITION, THEY ENCOUNTERED LARGE AMOUNTS OF BLACK STAINED SYNOVIAL TISSUE, WHERE THEY WERE EXCISED. THEY ALSO FOUND MAJOR OSSEOUS DEFECT OF LEFT PELVIC REGION AND THIGH. PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 21992322 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BHR RIGHT PROCEDURE ON (B)(6) 2012. AFTER THE PROCEDURE, THE PATIENT WOKE UP WITH PAIN. AN X-RAY TAKEN ON (B)(6) 2014 SHOWED THAT THE PATIENT HAD A RIGHT ANTERIOR DISLOCATION THEREFORE WAS TAKEN TO THE OR FOR A CLOSED REDUCTION UNDER GENERAL ANESTHESIA. THE PATIENT HAS BEEN AFFECTED BY THE FOLLOWING SYMPTOMS AFTER THE IMPLANTATION OF THE DEVICES PAINFUL RIGHT BHR WITH FEMORAL NEURAPRAXIA, ANTERIOR HIP PAIN/PSOAS IRRITATION, LATERAL HIP PAIN/ABDUCTION DYSFUNCTION, AND ILIOPSOAS TENDONITIS. NO REVISION HAS BEEN PLANNED. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: Headache; Joint Dislocation; Muscle/Tendon Damage; Nerve Damage; Pain

  MAUDE report 20318271 ↗
• InjuryJul 4, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING BHMH-THA ON (B)(6) 2006 DUE TO AVASCULAR NECROSIS OF HIP. PATIENT SUFFERED FROM INFECTED LEFT HIP ARTHROPLASTY AS WELL AS PAIN WITH A MARKED INCREASE IN HIS INFLAMMATORY MARKERS AND CELL COUNT AND METAL IONS LEVELS. ALSO, THE ACETABULAR COMPONENT APPEARED RELATIVELY INCLINED ON THE RADIOGRAPHIC VIEWS, POTENTIALLY INCREASING THE EDGE LOADING ON THAT IMPLANT AND ION PRODUCTION. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2012, DURING WHICH BOTH RESURFACING COMPONENTS WERE EXPLANTED. IT WAS CLEAR THERE HAD BEEN SOME FRETTING OF THE FEMORAL HEAD ON THE TRUNNION. THE TRUNNION ITSELF APPEARED TO BE IN GOOD CONDITION OVERALL, HOWEVER, ON THE INSIDE OF THE FEMORAL THERE WAS SOME BLACKENED MATERIAL, WHICH LIKELY WAS THE POTENTIAL WEAR GENERATING SOURCE FOR METAL IONS. POSTERIORLY, THERE WAS A DEFECT TRACKING AROUND THE BACK OF THE FEMUR. THIS MATERIAL IN THIS AREA APPEARED TO BE DIFFERENT THAN THE INFECTED MATERIAL THAT WAS IDENTIFIED PROXIMALLY IN THE JOINT LEVEL. THIS HAD MORE OF A CASEATING TYPE APPEARANCE AND CONSISTENCY AND MAY IN FACT HAVE BEEN SECONDARY TO METAL DEBRIS. PATIENT WAS TAKEN OFF THE OPERATING TABLE AN

  Patient problems: Metal Related Pathology

  MAUDE report 19674981 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON 2007, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS OR CONDITIONS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE ACETLR CUP HAP 58MM W/ IMPTR AND MODULAR HEAD WERE EXCHANGED. IT WAS NOTICED THAT THERE WAS SUBSTANTIAL PSEUDO-TUMOUR IN THE INFERIOR PORTION OF THE ACETABULUM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 18979588 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT BHR SURGERY ON (B)(6) 2008 BECAUSE THE PATIENT SUFFERED A SIGNIFICANT CARTILAGE DEGENERATION AND OSTEOPHYTOSIS ABOUT THE FEMORAL HEAD AND ACETABULUM. THE PATIENT PRESENTED ABDUCTOR WEAKNESS, PAINS IN HER HIP, AND ELEVATED ION LEVELS AND MRI PSEUDOTUMOR. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY PERFORMED ON (B)(6) 2014. DURING SURGERY, IT WAS NOTICED A CHRONIC ABDUCTOR TEAR WITHOUT SIGNIFICANT NECROSIS BUT SIGNIFICANT SCARRING. ALSO, IT WAS FOUND SOME CASEOUS TYPE TISSUE PRESENT. NO EVIDENCE OF NECROSIS AND PSEUDOTUMOR BEHIND THE CUP WERE FOUND. WHEN THE HEAD WAS REMOVED IT WAS FOUND EVIDENCE OF TRUNNIONOSIS BUT NOT SEVERE IN NATURE. A ACETLR CUP HAP 58MM W/ IMPTR, A BHR MODULAR HEAD 50MM AND A MODULAR SLEEVE -4MM 12/14 WERE EXPLANTED AND A 58MM MULTI-HOLE TRABECULAR METAL MODULAR ACETABULAR CUP, A 6.5 X25, 15- AND 25-MM SCREWS, A 36+4 OXINIUM HEAD AND A TRILOGY LINER 36 ID, 58MM OD WERE IMPLANTED. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION.

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

  MAUDE report 18753639 ↗
• InjuryFeb 8, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A RIGHT THA-BHMH REVISION SURGERY WAS PERFORMED ON (B)(6) 2021, DUE TO METALLOSIS AND THE PATIENT EXPERIENCING PAIN. THE RIGHT PRIMARY SURGERY HAD BEEN PERFORMED ON (B)(6) 2008. DURING THE REVISION SURGERY A MODERATE AMOUNT OF METAL STAINING, DEVITALIZED TISSUE ADJACENT TO THE CUP AND FEMORAL HEAD AND SYNOVITIS WAS FOUND. THE ACETABULAR CUP AND MODULAR HEAD WERE EXCHANGED FOR AN OXINIUM FEMORAL HEAD AND XLPE DUAL MOBILITY CUP. THE PATIENT WAS TAKEN TO PACU IN STABLE CONDITION, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18672738 ↗
• InjuryFeb 7, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A LEFT THA-BHMH REVISION SURGERY WAS PERFORMED ON (B)(6) 2021, DUE TO A LARGE METAL ON METAL HEAD AND ELEVATED METAL ION LEVELS. THE LEFT PRIMARY SURGERY HAD BEEN PERFORMED ON (B)(6) 2008. DURING THE REVISION SURGERY A MODEST AMOUNT OF METAL STAINING WITHIN SCAR TISSUE AND SOFT TISSUES, AND SYNOVITIS WAS FOUND. THE ACETABULAR CUP AND MODULAR HEAD WERE EXCHANGED FOR AN OXINIUM FEMORAL HEAD AND A DUAL MOBILITY CUP. THE PATIENT WAS TAKEN TO PACU IN STABLE CONDITION, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 18663894 ↗
• InjurySep 30, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A METAL-ON-METAL RIGHT TOTAL HIP ARTHROPLASTY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED COBALT LEVEL AT 270 (H) AND CHROMIUM LEVELS AT 31.0 (H), FURTHERMORE, INCREASED SUBSIDENCE OF THE FEMORAL STEM WAS FOUND WHEN COMPARED WITH THE PREVIOUS ONE WHICH RAISED SUSPICION FOR COMPONENT LOOSENING. A COMPUTERIZED TOMOGRAPHY (CT) WAS RECOMMENDED TO RULE OUT AN ACUTE PERIPROSTHETIC FRACTURE. HOWEVER, RADIOGRAPHIC FINDINGS WERE THE FOLLOWING: STABLE APPEARANCE AND ALIGNMENT OF LEFT TOTAL HIP ARTHROPLASTY, DEGENERATIVE CHANGES IN THE LOWER LUMBAR SPINE AND AT THE SACROILIAC JOINTS, AND SCLEROSIS ABOUT SYMPHYSIS PUBIS LIKELY REFLECT LONG-STANDING STRESS-RELATED CHANGES. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON AN UNKNOWN DATE.

  Patient problems: Infiltration into Tissue; Metal Related Pathology

  MAUDE report 15519097 ↗
• InjuryMay 24, 2022Biocompatibility; Biocompatibility

  US LEGAL: BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2007 DUE TO PROGRESSING DISABLING OF BOTH HIPS, PAIN, AND AVASCULAR NECROSIS, THE PATIENT SUFFERED LEFT HIP IMPINGEMENT, FOR WHICH LEFT REVISION SURGERY WAS CONDUCTED ON (B)(6) 2007 (COVERED UNDER (B)(4)). AFTER THAT EVENT, THE PATIENT EXPERIENCED HETEROTOPIC OSSIFICATION AND ELEVATED METAL IONS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021, IN WHICH LARGE FLUID COLLECTION IN THE HIP WITH LOSS OF ANTERIOR CAPSULE, LARGE ABDUCTOR TEAR, SIGNIFICANT ANTERIOR HETEROTOPIC BONE FORMED IN ANTERIOR THIGH MUSCULATURE WERE FOUND. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Cyst(s); Extraskeletal ossification; Infiltration into Tissue; Metal Related Pathology; Muscle/Tendon Damage

  MAUDE report 14487421 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL: BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2007 DUE TO PROGRESSING DISABLING OF BOTH HIPS, PAIN, AND AVASCULAR NECROSIS, THE PATIENT SUFFERED LEFT HIP IMPINGEMENT, FOR WHICH LEFT REVISION SURGERY WAS CONDUCTED ON (B)(6) 2007. AFTER THAT EVENT, THE PATIENT EXPERIENCED HETEROTOPIC OSSIFICATION AND ELEVATED METAL IONS, FOR WHICH A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT EXPERIENCED PARTIAL SCIATIC NERVE PALSY, LEG LENGTH DISCREPANCY AND LEFT HIP GREATER TROCHANTERIC FRACTURE. THIS ADVERSE EVENT WAS TREATED WITH A THIRD REVISION SURGERY ON (B)(6) 2021. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Hip Fracture; Nerve Damage; Unequal Limb Length

  MAUDE report 14487326 ↗
• 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 14487262 ↗
• InjuryMay 24, 2022Malposition of Device; Biocompatibility; Malposition of Device; Biocompatibility

  *US LEGAL* IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2007, THE PATIENT EXPERIENCED PAIN, METALLOSIS AND PROSTHESIS FAILURE. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE BHR FEMORAL HEAD WAS EXCISED AND REMOVED. INTRA-OPERATIVELY, THE ACETABULAR COMPONENT WAS WELL FIXED BUT POORLY POSITIONED IN SLIGHT RETROVERSION, AND THE SURGEON ELECTED TO REVISE IT AS WELL. CANCELLOUS ALLOGRAFT WAS UTILIZED TO FILL IN SOME OF THE ACETABULAR DEFECTS FROM THE METAL-ON-METAL REACTION. A FULL THA SYSTEM FROM A COMPETITOR¿S BRAND WAS IMPLANTED IN EXCHANGE. THE PATIENT TOLERATED WELL THE PROCEDURE AND WAS TRANSFERRED TO THE PACU UNIT IN STABLE CONDITION.

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

  MAUDE report 14487240 ↗
• InjuryMay 23, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR ON (B)(6) 2009 DUE TO LEFT OSTEOARTHRITIS. PLAINTIFF EXPERIENCES PAIN AND ELEVATED METAL IONS. PLAINTIFF UNDERWENT REVISION SURGERY ON LEFT HIP ON (B)(6) 2021. IT IS UNKNOWN THE STATUS OF THE PATIENT.

  Patient problems: Infiltration into Tissue; Metal Related Pathology

  MAUDE report 14470640 ↗
• 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 14465926 ↗
• InjuryMay 20, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PRIMARY BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2007, THE PATIENT EXPERIENCED ELEVATED SERUM COBALT AND CHROMIUM LEVELS, OSTEOLYSIS OF THE POSTERIOR FEMORAL NECK AND EXTENSIVE PSEUDOTUMOR FORMATION AROUND THE CAPSULE AND FEMORAL NECK. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETLR CUP HAP 58MM W/ IMPTR AND THE RESURFACING FEMORAL HEAD 50MM WERE EXPLANTED AND REPLACED WITH A THR PROSTHESIS CONSTRUCT. INTRAOPERATIVELY, THERE WERE CYSTS EXTENDING CENTRALLY TO THE FLOOR OF THE ACETABULUM AND ANTERIORLY INTO THE PUBIS WITH A LARGE DEFECT IN THE POSTERIOR WALL. ALL OF THESE WERE DEBRIDED TO HEALTHY BONE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Cyst(s); Metal Related Pathology; Osteolysis

  MAUDE report 14462874 ↗
• InjuryMay 18, 2022Biocompatibility; Biocompatibility

  *US LEGAL* IT WAS REPORTED THAT THE PLAINTIFF SUFFERED FROM A PURULENT INFECTION OF THE LEFT HIP AND NEEDED AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2022. DURING THIS PROCEDURE, A SIGNIFICANT AMOUNT OF GREY NECROTIC APPEARING TISSUE WAS OBSERVED, WHICH IS INDICATIVE FOR METALLOSIS. UNFORTUNATELY, THE PATIENT CONTINUED TO BE FEBRILE AND BEGAN HAVING CELLULITIS AROUND THE INCISION AND A CT GUIDED ASPIRATION CONFIRMED RECURRENT INFECTION. A 2-STEP REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2020 (FIRST STEP) AND ON (B)(6) 2021 (SECOND STEP). THE PRIMARY BHR LEFT HIP SURGERY WAS PERFORMED ON (B)(6) 2009.

  Patient problems: Metal Related Pathology; Unspecified Infection

  MAUDE report 14429410 ↗
• InjuryApr 18, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT, AFTER A LEFT HIP BHR SURGERY WAS PERFORMED ON (B)(6) 2014, THE PATIENT EXPERIENCED INCREASED METAL ION LEVELS AND PAIN WITH SOME EVIDENCE OF PSEUDOTUMOR. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A THA SYSTEM. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology; Pain; Solid Tumor

  MAUDE report 14132569 ↗
• InjuryMar 28, 2022Adverse 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 SURGERY OF THE RIGHT HIP DUE TO AN INFECTION ON (B)(6) 2021. THE PATIENT HAD AN ASPIRATION WITH GRAM-POSITIVE COCCI NOTED. DURING THE REVISION SURGERY, BOTH BHR COMPONENTS WERE EXPLANTED AND REPLACED WITH ANTIBIOTIC SPACERS. THE PATIENT WAS HOSPITALIZED FOR CONTINUOUS IV ANTIBIOTICS THERAPY. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 13927160 ↗
• 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: Insufficient Information; Metal Related Pathology; Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 13896773 ↗
• 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 13101488 ↗
• InjuryDec 7, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A MEDICALLY INDICATED REVISION OF THE RIGHT HIP IN (B)(6) 2020 DUE TO PROGRESSIVE PAIN AND ELEVATED CHROMIUM AND COBALT LEVELS IN BLOOD. DURING THE REVISION, SURGICAL FINDINGS CONFIRMED THE PRESENCE OF FLUID IN THE JOINT AND SOFT TISSUE EROSION BECAUSE OF METAL-ON-METAL WEAR. DURING THE REVISION SURGERY, BOTH BHR COMPONENTS WERE EXPLANTED AND REPLACED WITH A TOTAL HIP SYSTEM. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE REPORTED. THE PRIMARY RIGHT BHR SURGERY WAS PERFORMED IN (B)(6) 2014.

  Patient problems: Metal Related Pathology

  MAUDE report 12951502 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2008, THE PLAINTIFF EXPERIENCED A POST-OPERATIVE CELLULITIS WHICH REQUIRED READMISSION TO HOSPITAL IN TWO OCCASIONS, IN ORDER TO PERFORM TWO INCISION AND DRAINAGE PROCEDURES ON (B)(6) 2008 AND (B)(6) 2008. DURING BOTH PROCEDURES, A SYNOVECTOMY WAS PERFORMED, WHERE THE HIP AND WOUND WERE COPIOUSLY IRRIGATED. AFTER THE SECOND PROCEDURE, AND ADJUSTMENT IN HIS IV ANTIBIOTIC THERAPY WAS PRESCRIBED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON THE 3RD POSTOPERATIVE DAY.

  Patient problems: Bacterial Infection

  MAUDE report 12846425 ↗
• InjuryOct 22, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT HIP ON (B)(6) 2004, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. DURING THIS PROCEDURE, THE ACETLR CUP HAP 58MM W/ IMPTR AND THE RESURFACING FEMORAL HEAD 50MM WERE EXPLANTED AND REPLACED WITH A THA CONSTRUCT. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Cyst(s); High metal ion levels; Insufficient Information

  MAUDE report 12681573 ↗
• InjurySep 27, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PRIMARY BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S RIGHT HIP ON (B)(6) 2007, THE PLAINTIFF EXPERIENCED METALLOSIS, ELEVATED SERUM CHROMIUM AND COBALT LEVELS, PAIN, LOSS OF BALANCE, DIZZINESS, AMBULATORY DIFFICULTIES, TISSUE DEHISCENCE AND NECROSIS, BONE NECROSIS, HYPERTROPHIC SCARRING AND LUMBAR STRAIN. ADDITIONAL SURGERIES WERE PERFORMED ON (B)(6) 2017 AND ON (B)(6) 2017 TO ADDRESS THIS EVENT BY REPLACING THE PRODUCTS. THERE WAS NOTICED AN INCREASED SUBSIDENCE OF THE FEMORAL STEM WHEN COMPARED WITH PREVIOUS, WHICH RAISED SUSPICION FOR COMPONENT LOOSENING. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Dizziness; Metal Related Pathology; Necrosis; Wound Dehiscence

  MAUDE report 12532561 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040033. One submission often covers many models, so check the product and lot details in each record.

• Z-2242-2021 · Jul 14, 2021 · Terminated
  smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
• Z-2267-2018 · May 11, 2018 · Terminated
  Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
• Z-2268-2018 · May 11, 2018 · Terminated
  Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Siz
• Z-2746-2015 · Jun 3, 2015 · Terminated
  Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74
• Z-2747-2015 · Jun 3, 2015 · Terminated
  Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Pro
• Z-2745-2015 · Jun 3, 2015 · Terminated
  Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 M
• Z-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component.
• Z-0026-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component.
• Z-0016-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
• Z-0029-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component.
• Z-0018-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant component.
• Z-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component.
• Z-0031-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component.
• Z-0033-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component.

…and 14 more.