BIRMINGHAM HIP RESURFACING (BHR) 74120160Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 03596010502612), received between May 11, 2017 and Mar 15, 2026 — classified as 62 injuries.

The most frequently reported specific device problem is “Biocompatibility” (18 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 62 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON AN UNSPECIFIED DATE, OSTEOLYSIS WAS OBSERVED BEHIND THE ACETABULAR CUP. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026 IN WHICH A ACETLR CUP HAP 60MM W/ IMPTR WAS EXCHANGED FOR A ZIMMER G7 CUP. PATIENT'S CURRENT HEALTH STATUS IS RECOVERING.

  Patient problems: Osteolysis

  MAUDE report 24601480 ↗
• InjuryOct 27, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, ON A CLINICAL STUDY, AFTER A BHR SURGERY WAS PERFORMED ON (B)(6) 2006, ON (B)(6) 2011 THE PATIENT EXPERIENCED ATRIAL FIBRILLATION DUE TO ELEVATED ION LEVELS. IT IS UNKNOWN HOW THE PATIENT WAS TREATED BACK THEN. AFTER THIS, THE PATIENT EXPERIENCED AGAIN A PAROXYSMAL ATRIAL FIBRILLATION AND UNDERWENT ELECTRICAL CARDIOVERSION ON (B)(6) 2015. PATIENT HAD 2 EPISODES OF RECURRENT ATRIAL FIBRILLATION, 1 OF THEM LASTED 24 HOURS AND THEN IT WAS REVERTED BACK TO NORMAL. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Atrial Fibrillation; High metal ion levels

  MAUDE report 23398612 ↗
• InjuryAug 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) ACETLR CUP HAP 60MM W/ IMPTR AND ONE (1) RESURFACING FEMORAL HEAD 54MM WERE REVISED AND REPLACED WITH OXI HEAD/POLY. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22839587 ↗
• InjuryJul 14, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT BIRMINGHAM HIP RESURFACING (BHR) TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 DUE TO COXARTHROSIS. FIVE YEARS POST-IMPLANTATION, THE PATIENT EXPERIENCED PAIN AND ELEVATED METAL ION LEVELS (CHROMIUM 111.8 MCG/L, COBALT 57.0 MCG/L). A REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 DUE TO METALLOSIS. INTRAOPERATIVE FINDINGS INDICATED METALLOSIS AT THE FEMORAL STEM TAPER AND SYNOVIUM. THE SYNERGY STEM REMAINED IN SITU, AND ALTERNATIVE IMPLANTS WERE USED FOR THE REVISION. NO PROCEDURAL DELAY WAS REPORTED, AND THE FINAL PATIENT OUTCOME WAS NOT SPECIFIED.

  Patient problems: Metal Related Pathology

  MAUDE report 22492882 ↗
• InjuryApr 29, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR IN HIS RIGHT HIP JOINT ON (B)(6) 2006, PATIENT EXPERIENCED METALLOSIS SECONDARY TO METAL ON METAL ARTICULATION COMPLICATED BY PAIN AND FAILURE DUE TO PSEUDOTUMOR. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY. DURING PROCEDURE, IT WAS FOUND THAT THERE WAS A LARGE FLUID FILLED CYST BLACK/GREY AND ENCAPSULATED. THERE WAS SCLEROTIC TRACT WITH METAL DEBRIS FROM WHERE THE STEM WAS REMOVED. IN ADDITION, INFERIORLY TO THE ACETABULUM, THERE WAS ANOTHER AREA OF DEFICIENT BONE AND ALSO METALLIC DEBRIS. PATIENT WAS TRANSFERRED IN STABLE CONDITION TO THE PACU.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 21931869 ↗
• InjurySep 5, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR CUP REVISION SURGERY ON (B)(6) 2009 DUE TO RIGHT HIP CUP INSTABILITY. PATIENT SUFFERED FROM INFECTED RIGHT HIP RESURFACING. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A TWO-STAGE REVISION SURGERY. THE FIRST-STAGE WAS PERFORMED ON (B)(6) 2011, DURING WHICH AN EXCISION ARTHROPLASTY, SYNOVECTOMY AND DEBRIDEMENT WITH HO EXCISION AND INSERTION OF PROSTALAC CEMENT SPACER WAS DONE. WHILE DOING THE PROCEDURE, A SIGNIFICANT AMOUNT OF SCAR AROUND THE CAPSULE WAS EXCISED. THERE WAS A VERY SMALL DEFECT MEDIALLY AROUND THE FOVEA WHICH APPEARED TO BE OSTEOLYSIS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS ADMITTED TO RECOVERY UNEVENTFULLY AFTER A JONES DRESSING WAS PLACED ON THE RIGHT LEG. PATIENT WAS TOUCH WEIGHT BEARING ON IV ANTIBIOTICS FOR SIX WEEKS.

  Patient problems: Medical device site infection

  MAUDE report 20145813 ↗
• InjurySep 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER UNDERGOING A BHR ON (B)(6) 2009 DUE TO RIGHT HIP OSTEOARTHRITIS. PATIENT SUFFERED FROM RIGHT HIP CUP INSTABILITY. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2009, DURING WHICH THE ACETLR CUP HAP 60MM W/ IMPTR WAS EXPLANTED. IN ADDITION, WHILE DOING THE PROCEDURE, WHEN THE HIP WAS DISLOCATED AND IT WAS FOUND THAT THE CUP WAS REALLY VERTICAL AND RETROVERTED. THE CUP WAS EXTRACTED USING ONE WIRE THREADED THROUGH THE HOLE IN THE CUP. IT WAS TRIED TO GET THE SAME CUP BACK ON AGAIN USING THE WIRE INSERTER, HOWEVER, THERE WAS GREAT DIFFICULTY IN GETTING THAT CUP IN BECAUSE OF INSTABILITY OF THE INSERTER ITSELF. A ADDRESSING WAS PUT ON AND THE PATIENT WAS TRANSFERRED TO THE BED AND TAKEN TO THE RR WITHOUT ANY COMPLICATIONS. POSTOPERATIVE X-RAY CONFIRMED THAT THE CUP PROTHESIS WAS IN GOOD CONDITION AND HIS POSTOPERATIVE EXAM IN THE RR SHOWED THAT THE SCIATIC NERVE WAS NORMAL.

  Patient problems: Failure of Implant

  MAUDE report 20145746 ↗
• InjuryJul 3, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT REPORTED RIGHT HIP PAIN, AND SEVERAL FALLS 4 YEARS AFTER THE IMPLANTATION OF A LEFT BHR IN 2010. THE PATIENT WAS SCHEDULED FOR A LEFT HIP REVISION SURGERY DUE TO FAILED TOTAL HIP, HOWEVER, IT IS UNKNOWN IF THE SURGERY WAS ACTUALLY PERFORMED. ALSO, TEST RESULTS PERFORMED 6 YEARS AFTER THE PRIMARY SURGERY REVEALED ELEVATED METAL ION LEVELS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Arthralgia; High metal ion levels

  MAUDE report 19671905 ↗
• InjuryMay 22, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A BILATERAL PLAINTIFF UNDERWENT A LEFT PRIMARY BHR ON (B)(6) 2018. PATIENT STARTED EXPERIENCING SYSTEMIC COMPLAINTS SUCH AS NAUSEA ON A DAILY BASIS, DIZZINESS, NUMBNESS AND TINGLING DOWN BOTH LEGS, AND ELEVATED LEVELS OF CHROMIUM COBALT LEVELS. A T LYMPHOCYTE TRANSFORMATION TEST REVEALED THEY WERE HIGHLY REACTIVE TO NICKEL. THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IT IS UNKNOWN WHICH DEVICES WERE IMPLANTED. PATIENT'S HEALTH STATUS IS UNKNOWN. FURTHER COMPLICATIONS WERE NOT REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 19378175 ↗
• InjuryMay 22, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A BILATERAL PLAINTIFF UNDERWENT A RIGHT PRIMARY BHR ON (B)(6) 2018. PATIENT STARTED EXPERIENCING SYSTEMIC COMPLAINTS SUCH AS NAUSEA ON A DAILY BASIS, DIZZINESS, NUMBNESS AND TINGLING DOWN BOTH LEGS, AND ELEVATED LEVELS OF CHROMIUM COBALT LEVELS. MRIS SHOWED NO EVIDENCE OF PSEUDOTUMOR OR FLUID COLLECTION AND X-RAYS SHOW WELL FIXED AND ALIGNED FEMORAL AND ACETABULAR COMPONENTS. NEVERTHELESS, A T LYMPHOCYTE TRANSFORMATION TEST REVEALED THEY WERE HIGHLY REACTIVE TO NICKEL. THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH A SMALL AREA OF LYSIS WAS FOUND IN ANTERIOR ASPECT OF ACETABULUM. BOTH BHR COMPONENTS WERE EXCHANGED FOR A S+N THA SYSTEM. PATIENT TOLERATED THE PROCEDURE WELL, AND WAS TAKEN TO PACU IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 19378159 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PLAINTIFF UNDERWENT A BHR RIGHT THA SURGERY ON (B)(6)2011, HE EXPERIENCED IMPLANT PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6)2023, IN WHICH THE SURGEON FOUND THE METAL ON METAL IMPLANTS INTACT, WITHOUT ANY BROKEN PIECES AND NO PSEUDO TUMOR. THE PREVIOUS BHR FEMORAL HEAD AND ACETABULAR CUP WERE EXPLANTED AND REPLACED BY ZIMMER IMPLANTS. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Implant Pain

  MAUDE report 18694718 ↗
• InjuryOct 30, 2023Migration; Migration

  IT WAS REPORTED THAT, AFTER A THR, HAD BEEN PERFORMED IN 2016, THE PATIENT EXPERIENCED MOBILIZATION OF THE PROTHESIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. ONE (1) ACETLR CUP HAP 60MM W/ IMPTR AND ONE (1) RESURFACING FEMORAL HEAD 54MM WERE REMOVED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 18035905 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING OF THE RIGHT HIP PERFORMED ON (B)(6) 2005, THE PATIENT SUFFERED FROM A PAINFUL HIP. THIS CONDITION WAS TREATED BY PERFORMING A REVISION SURGERY OF THE RIGHT HIP DONE ON (B)(6) 2023, DURING WHICH THE BHR ACETABULAR CUP AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH THA SMITH AND NEPHEW IMPLANTS. AFTER THE SURGERY, AN AP PELVIC X-RAY WAS OBTAINED IN THE RECOVERY ROOM AND SHOWED SATISFACTORY POSITIONING OF THE COMPONENTS. PATIENT CAN BE WEIGHT-BEARING AS TOLERATED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Arthralgia

  MAUDE report 17724869 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PRIMARY SURGERY WHEN ATTEMPTING THE BIRMINGHAM PROCEDURE, THE ORIGINAL PLANNED SURGERY WAS ABORTED DUE TO INTRAOPERATIVE BLEEDING WHICH REQUIRED THE FEMORAL NECK CUT TO BE MADE. THERE WAS FELT TO BE A SIGNIFICANT BRANCH OF THE FEMORAL CIRCUMFLEX VESSELS THAT CAUSED THIS INTRAOPERATIVE BLEEDING. THE BLOOD LOSS WAS CONTROLLED WITH THE USE OF CELL SAVER. THE PATIENT RECEIVED 250 CC OF BLOOD REINFUSED DURING THIS PROCEDURE. AFTER ADEQUATE HEMOSTASIS, THE PROCEDURE WAS FINISHED CONVERTING THE BIRMINGHAM PROCEDURE TO A TOTAL HIP ARTHROPLASTY. THE PATIENT WAS RETURNED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 17303081 ↗
• InjuryFeb 10, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT WAS IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2009, THE PATIENT HAD AN MIR OF THE LEFT HIP PERFORMED ON (B)(6) 2020, IT SHOWED A NONSPECIFIC FLUID COLLECTION THAT DISTENDS THE ILIOPSOAS BURSA, AS WELL AS A QUESTIONABLE MILD FLUID THAT SURROUNDS THE FEMORAL STEM, ALSO A TRACE OF FLUID IS NOTED WITHIN THE TROCHANTERIC BURSA REGION INFERIORLY. IT WAS STATED THAT AN ADVERSE LOCAL TISSUE REACTION CANNOT BE EXCLUDED. PATIENT¿S COBALT LEVEL IN BLOOD WAS ELEVATED. THIS WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

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

  MAUDE report 16351295 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISE A 20-YEAR-OLD BHR RESURFACING DUE TO PAIN. NO BLACKENING OF TISSUES WAS NOTICED. THE BHR ACETABULAR CUP HAP SZ 60 MM WAS EXPLANTED. IT IS UNKNOWN THE CURRENT HEALTH STATE OF THE PATIENT.

  Patient problems: Pain

  MAUDE report 15266579 ↗
• InjuryMay 31, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2021 SECONDARY TO SQUEAKING NOISE, METALLOSIS, ELEVATED METAL ION LEVELS AND PAIN. DURING THE REVISION, THE CUP WAS PRESERVED, AND THE FEMORAL HEAD WAS EXPLANTED. THE SYSTEM WAS CONVERTED TO A THA. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PRIMARY RIGHT HIP BHR PROCEDURE WAS PERFORMED ON (B)(6) 2010.

  Patient problems: Metal Related Pathology

  MAUDE report 14549371 ↗
• InjuryMay 31, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF EXHIBITED ELEVATED METAL ION LEVELS IN BLOOD AFTER A LEFT HIP BHR PRIMARY SURGERY (ABOUT 20 MCG/L). NO REVISION SURGERY OR ANY OTHER MEDICAL INTERVENTION HAS BEEN INDICATED FOR THE PATIENT´S LEFT HIP, HOWEVER, THE PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY DUE TO METALLOSIS ON (B)(6) 2021 (COVERED UNDER CASE-(B)(4)). THIS CASE WAS CREATED BECAUSE WE CAN NOT RULE OUT THE CONTRIBUTION OF THE LEFT HIP BHR SYSTEM IN THE ALLEGED ELEVATION OF METAL ION LEVELS. THE PRIMARY LEFT HIP BHR SURGERY WAS PERFORMED ON (B)(6) 2010.

  Patient problems: Metal Related Pathology

  MAUDE report 14549297 ↗
• InjuryMay 25, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED METALLOSIS, PAIN, INSTABILITY, AND THREE DISLOCATIONS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY AND OPEN BIOPSY ON (B)(6) 2022. AFTER THIS PROCEDURE, THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION. IN ADDITION, THE PATIENT HAD PREVIOUSLY UNDERWENT A PRIMARY RIGHT BHR SURGERY ON (B)(6) 2007, HOWEVER, NO COMPLICATIONS HAVE BEEN REPORTED REGARDING THE RIGHT HIP.

  Patient problems: Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 14493712 ↗
• InjuryMay 12, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR-THA ON (B)(6) 2007 DUE TO SEVERE DEGENERATIVE OSTEOARTHRITIS, LEFT HIP COXA VARA, CHRONIC FEMORAL IMPINGEMENT, AND POST SCFE DEFORMITY. PLAINTIFF EXPERIENCES SWELLING AND HIGH COBALT LEVELS. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2021 WHERE THE MODULAR HEAD AND STEM WAS REMOVED, AND DEBRIDEMENT OF ALL FIBRINOUS AND INFECTED TISSUE WAS PERFORMED BUT DUE TO PATIENT¿S CARDIOPULMONARY STATUS IT WAS REQUIRED TO CLOSED AND WAIT FOR PATIENT STABILIZATION. REVISION SURGERY WAS RESUME ON (B)(6) 2021 WHERE AN ACETABULAR COMPONENT WAS REMOVED, AND IT WAS FOUND A LARGE SUPERIOR CYST INSIDE THE ILIUM. PATIENT STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology; Unspecified Infection

  MAUDE report 14385686 ↗
• InjuryApr 20, 2022Biocompatibility; Biocompatibility

  US LEGAL: BILATERAL PATIENT. IT IS REPORTED THAT, AFTER A LEFT BHR ON (B)(6) 2012, PLAINTIFF HAS EXPERIENCED EXTREME HIP PAIN, LOCAL ADVERSE TISSUE REACTION AND METALLOSIS. PLAINTIFF IS SCHEDULED FOR MEDICALLY INDICATED REVISION SURGERY ON THE LEFT BHR IMPLANTS ON (B)(6) 2022. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14161400 ↗
• InjuryApr 19, 2022Biocompatibility; Biocompatibility

  US LEGAL, IT WAS REPORTED THAT, AFTER A LEFT BHR-THA WAS PERFORMED ON (B)(6) 2011 DUE TO HYPERTROPHIC OSTEOARTHRITIS, THE PATIENT EXPERIENCED A LEFT INFECTION AND INFLAMMATORY REACTION DUE TO ELEVATED SERUM COBALT AND CHROMIUM LEVELS. THIS ADVERSE EVENT WAS TREATED WITH A LEFT REVISION SURGERY ON (B)(6) 2021, IN WHICH A SPACER REPLACEMENT/SYNOVECTOMY, BONE EXCISION AND A TROCHANTERIC OSTEOTOMY REPAIR WERE PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fistula; Fluid Discharge; Metal Related Pathology; Unspecified Infection

  MAUDE report 14140559 ↗
• InjuryApr 11, 2022Biocompatibility; Biocompatibility

  *US LEGAL* IT WAS REPORTED THAT, AFTER A RIGHT BHR-THA WAS PERFORMED ON (B)(6) 2011 DUE TO HYPERTROPHIC OSTEOARTHRITIS, THE PATIENT EXPERIENCED ELEVATED SERUM COBALT AND CHROMIUM LEVELS. PLAINTIFF UNDERWENT A LEFT REVISION SURGERY ON (B)(6) 2021 (COVERED UNDER CASE (B)(4)). IT IS UNKNOWN IF A RIGHT REVISION SURGERY HAS BEEN PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Infiltration into Tissue; Metal Related Pathology

  MAUDE report 14075404 ↗
• InjuryNov 30, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2021, THE PATIENT FELL AND EXPERIENCED THE BREAKAGE OF AN ACETABULAR CUP HAP SIZE 52/60 AND A RESURFACING FEMORAL HEAD 54MM. THIS INCIDENT WAS SOLVED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Fall

  MAUDE report 12893476 ↗
• InjuryMay 20, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF LEFT HIP ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN AND ELEVATED METAL ION LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS REVISION SURGERY, THE SURGEON NOTICED THAT THE SYNOVIAL TISSUE WAS SOMEWHAT METALLIC STAINED, AND THERE WAS A LITTLE REACTIVE CYST BEHIND THE CUP. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11858027 ↗

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-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-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-0028-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
• Z-0025-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component.
• Z-0030-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0019-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. 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-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component.
• Z-0021-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component.
• Z-0032-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component.
• Z-0023-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component.

…and 14 more.