BIRMINGHAM HIP RESURFACING (BHR) 74123148Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 03596010552426), received between Jul 3, 2018 and Jul 1, 2026 — classified as 54 injuries.

The most frequently reported specific device problem is “Biocompatibility” (29 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERWENT A BHR IN 2016, PATIENT EXPERIENCED HEAVY METAL POISONING OF THE BODY ALONG WITH PAIN. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2026, DURING WHICH THE FEMORAL HEAD 48MM & ACETABULAR CUP HAP SIZE 48/54 WERE EXCHANGED. PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: High metal ion levels; Pain

  MAUDE report 25681015 ↗
• InjuryFeb 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED IN 2012, THE PATIENT PRESENTED PAINFUL HIP. THE PAIN WAS PRESENT UNTIL THIS YEAR. THIS ADVERSE EVENT WAS SOLVED BY THR REVISION SURGERY ON (B)(6) 2026, IN WHICH THE FEMORAL HEAD 48MM WAS REMOVED. THE ACETLR CUP HAP 48MM W/ IMPTR WAS MAINTAINED. PERFORMED A THA SURGERY WITH A BDMH HEAD TO MATCH THE 54-CUP. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Implant Pain

  MAUDE report 24410370 ↗
• InjuryDec 15, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2015, THE PATIENT HAS EXPERIENCED HIP PAIN, INSTABILITY, WITH SURROUNDING AREA FROM APPARENT METALLOSIS. NO REVISION SURGERY AND NO ADDITIONAL TREATMENT WAS INDICATED BY THE HCP.

  Patient problems: Foreign Body Reaction; Joint Laxity; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 23803391 ↗
• InjuryOct 15, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT BHR ON (B)(6) 2013 DUE TO OSTEOARTHRITIS, THE PATIENT STARTED TO EXPERIENCE PAIN AND WAS WORSE WHEN HE FIRST GOT UP. THE PATIENT IS A BILATERAL BHR PATIENT. LAB TESTS REVEALED ELEVATED COBALT AND CHROMIUM IONS LEVELS. THE RIGHT HIP WAS REVISED ON 25-JUL-2024 ((B)(4)), WHERE HE WAS DIAGNOSED WITH METALLOSIS, BUT THE LEFT HIP HASN¿T BEEN REVISED AT THE TIME. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288042 ↗
• InjuryMay 7, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PATIENT UNDERWENT A RIGHT HIP METAL-ON-METAL BHR THA PERFORMED ON (B)(6) 2009, A RIGHT REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 DUE TO PAIN AND WEAKNESS, AND A CONVERSION TO THA WAS PERFORMED. THE PATIENT ALSO HAD ELEVATED CHROMIUM AND COBALT LEVELS. A MODERATELY SEVERE SYNOVITIS WITH EXTENSIVE POSTERIOR LATERAL DEBRIS WERE NOTICED, CONSISTENT WITH PROBABLE PSEUDOCYSTS IN THE LATERAL AND POSTERIOR LATERAL ASPECT OF THE ACETABULUM, WITH SOME EROSIVE CHANGES NOTED. ACETABULAR COMPONENT REMAIN SOLID IN TERMS OF FIXATION. THERE WAS NO GROSS EVIDENCE OF INFECTION. THE FEMORAL HEAD WAS REMOVED AND REPLACED FOR MEDACTA SIZE 3 AMIS P FEMORAL COMPONENT WITH 48 MM O.D./ 28 MM I.D. DUAL MOBILITY LINER AND A 28 MM S (-3.5 MM) DELTA CERAMIC FEMORAL HEAD. THE ACETABULAR COMPONENT WAS RETAINED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Cyst(s); Erosion; Metal Related Pathology; Pain

  MAUDE report 21981218 ↗
• InjuryMay 7, 2025Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT HIP METAL-ON-METAL BHR THA PERFORMED ON (B)(6) 2010, THE PATIENT STARTED TO FEEL STIFFNESS AND PAIN. AN MRI SCAN INDICATED FLUID AND WAS CONSISTENT WITH METALLOSIS. A LEFT REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IN WHICH A CLOUDY CYSTIC FLUID WAS FOUND IN AND ABOUT THE HIP JOINT, WITH HYPERTROPHIED SYNOVITIS. NO GROSS LOOSENING OF ACETABULAR COMPONENT WAS NOTICED. A CONVERSION TO THA WAS PERFORMED. THE FEMORAL HEAD WAS REMOVED AND REPLACED FOR AMIS SIZE 4_PFEMORAL COMPONENT WITH 48 MM OUTER DIAMETER DUAL MOBILITY LINER AND A SIZE 28_ S(- 3.5 MM)DELTA CERAMIC HEAD. THE ACETABULAR COMPONENT WAS RETAINED. NEARLY 4 WEEKS FOLLOWING THE LEFT HIP REVISION AND CONVERSION TO TOTAL HIP ARTHROPLASTY, THE PATIENT HAD BEEN DOING VERY WELL UNTIL HE BEGAN NOTICING PAIN AND SOME SWELLING WITH SOME ERYTHEMA IN AND AROUND THE INCISION, AND SOME AREA OF FLUCTUANCE. AN ADDITIONAL REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IN ORDER TO REMOVE MEDACTA 48 MM OUTER DIAMETER DUAL MOBILITY LINER WITH 28 MM S (-3.5 MM) DELTA CERAMIC HEAD AND REPLACE THEM FOR MEDACTA 48 MM OUTER DIAMETER DUAL MOBILITY LINER WITH 28 MM S (-3.5 MM) DELTA CERAM

  Patient problems: Foreign Body Reaction; Medical device site infection; Metal Related Pathology

  MAUDE report 21977979 ↗
• InjuryFeb 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A RIGHT BHR SURGERY PERFORMED ON (B)(6) 2019, THE PATIENT PRESENTED WITH PAIN AND X-RAY REVEALED SOME MIGRATION OF THE FEMORAL HEAD. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO ASEPTIC LOOSENING OF THE FEMORAL HEAD 48MM. ONLY THE FEMORAL HEAD WAS EXPLANTED, AND WAS REPLACED WITH A FEMORAL HIP STEM, HEAD, AND MATCHING BDMH. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 21420729 ↗
• InjuryDec 20, 2024Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HIP PAIN ON CONTRALATERAL SIDE. RADIOGRAPHS SHOWED LYTIC REGIONS IN THE PROXIMAL FEMUR AND ACETABULUM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024 TO EXCHANGE A FEMORAL HEAD 48MM TO A DUAL MOBILITY HEAD AS THE CUP WAS WELL FIXED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Osteolysis; Pain

  MAUDE report 20995890 ↗
• InjuryAug 6, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PATIENT WAS IMPLANTED A BHR RESURFACING FEMORAL HEAD 48MM, THEY HAD A METAL ALLERGY AND METALLOSIS COMPLICATIONS. A REVISION SURGERY IS CURRENTLY BEING RESCHEDULED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. FURTHER COMPLICATIONS WERE NOT REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 19924595 ↗
• InjuryJul 3, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PLAINTIFF RECEIVED A LEFT BHR SYSTEM ON 23-SEP-2011. THE BHR FAILED AND PATIENT EXPERIENCED PAIN AND ELEVATED COBALT CHROMIUM IONS, THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. DURING SURGERY THE ACETABULAR CUP WAS FOUND POSITIONED IN AN ACCEPTABLE ORIENTATION AND WAS KEPT IN PLACE, NECROTIC TISSUE WAS FOUND AROUND IT AND WAS REMOVED. THE HIP WAS CONVERTED INTO A THA USING S+N COMPONENTS. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology; Necrosis; Scar Tissue

  MAUDE report 19666335 ↗
• InjuryJun 23, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A BILATERAL PLAINTIFF UNDERWENT A LEFT BHR SURGERY ON (B)(6) 2012 AND WAS LATER DIAGNOSED WITH HIGH CHROMIUM COBALT LEVELS ON (B)(6) 2022. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, DURING WHICH A LARGE AREA OF FRANK METAL-STAINED TISSUE THAT HERNIATED THROUGH THE FASCIA WAS FOUND. THE ACETABULAR CUP WAS NOTICED TO BE IN GOOD POSITION AND WELL FIXED, THEREFORE IT WAS KEPT IN PLACE AND THE HIP WAS CONVERTED INTO A DUAL MOBILITY BIRMINGHAM WITH A DJO EMPOWR TOTAL HIP SYSTEM. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 19591635 ↗
• InjuryMay 29, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PATIENT UNDERWENT A LEFT BHR ON (B)(6) 2020. THEN THEY WERE DIAGNOSED WITH ASEPTIC LOOSENING, WEAR DEBRIS AND ELEVATED CHROMIUM AND COBALT LEVELS. A REVISION WAS CARRIED OUT ON (B)(6) 2022 TO RESOLVE THIS ADVERSE EVENT, AND THE HIP WAS CONVERTED INTO A DUAL MOBILITY THA USING S+N COMPONENTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Metal Related Pathology

  MAUDE report 19420761 ↗
• InjuryMay 29, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PLAINTIFF UNDERWENT A LEFT PRIMARY BHR ON (B)(6) 2010 AND IN 2023 THEY WERE TESTED FOR ELEVATED METAL IONS LEVELS. THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DURING WHICH EXTENSIVE CARTILAGE LOSS, DEGENERATION & EFFUSION WAS FOUND. THE BHR HIP WAS CHANGED INTO A BIRMINGHAM DUAL MOBILITY HIP WITH AN OXINIUM HEAD AND POLARSTEM. PATIENT WAS TRANSFERRED FROM THE OR TO REGULAR ROOM IN STABLE CONDITION. THEY WERE DISCHARGED ON (B)(6) 2024 AND REMAINED CLINICALLY STABLE.

  Patient problems: High metal ion levels

  MAUDE report 19420730 ↗
• InjuryFeb 8, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A LEFT BIRMINGHAM HIP RESURFACING ON (B)(6)2010 BECAUSE THE PATIENT SUFFERED A SEVERE DEGENERATIVE ARTHRITIS IN THE LEFT HIP. AFTER THIS PRIMARY PROCEDURE, THE PATIENT PRESENTED A LEFT HIP FLEXION WEAKNESS, GOT SOME COBALT CHROMIUM LEVELS SIGNIFICANTLY ELEVATED AND MRI WAS PERFORMED SHOWED A LOOSENING OF THE ACETABULAR COMPONENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022. DURING SURGERY, IT WAS NOTICED THAT THE ABDUCTORS WERE HEALTHY. A POSTERIOR CAPSULOTOMY WAS PERFORMED AND A LARGE AMOUNT OF DARK BLACK FLUID FROM THE HIP WAS EVACUATED. THERE WAS EVIDENCE OF METALOSIS, SIGNIFICANT AMOUNT OF PSEUDOTUMOR AND NECROTIC TISSUE. WHEN THE CUP WAS GOING TO BE EVALUATED, THERE WAS NO POSTERIOR WALL REMAINING, THE CUP WAS LARGELY INGROWN SUPERIORLY AND TO THE MEDIAL WALL, SO IT WAS DECIDED TO LEAVE THE CUP IN PLACE. BHR RESURFACING FEMORAL HEAD 48MM WAS REMOVED. COMPETITOR DEVICES WERE IMPLANTED TOGETHER WITH A SMITH AND NEPHEW OREO 48 MM OUTER DIAMETER DUAL MOBILITY HIGHLY CROSS-LINKED POLYETHYLENE. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Joint Laxity; Metal Related Pathology

  MAUDE report 18669323 ↗
• InjuryAug 30, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR WAS PERFORMED ON THE (B)(6) 2012, THE PATIENT EXPERIENCE HIP PAIN AND INCREASED METAL LEVELS. A PSEUDOTUMOUR WAS CONFIRMED PRE-OP BY MRI. THE REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022, TO TREAT THIS ADVERSE EVENT, DURING WHICH METALLOSIS AND OSTEOLYSIS OF THE FEMORAL NECK WAS FOUND. THE PATIENT RECEIVED A THA SYSTEM IN EXCHANGE.

  Patient problems: Metal Related Pathology

  MAUDE report 17658532 ↗
• InjuryMar 14, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2009, THE PATIENT SUSTAINED LEFT HIP PAIN AND ELEVATED COBALT AND CHROME LEVELS IN BLOOD (UNSPECIFIED CONCENTRATION). A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2018 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETABULAR CUP AND RESURFACING HEAD WERE EXPLANTED AND REPLACED WITH A THR SYSTEM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 16542397 ↗
• InjuryMar 13, 2023Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER A BHR RESURFACING RIGHT HIP SURGERY WAS PERFORMED DUE TO OSTEOARTHRITIS ON (B)(6) 2014 THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2022 DUE TO PROSTHETIC HIP IMPLANT FAILURE. DURING SURGERY, IT WAS NOTICED THAT THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND APPEARED TO BE NECROTIC. INSIDE THE FEMORAL COMPONENT WAS NECROTIC BONE AND CEMENT ON GROSS INSPECTION. THE FEMORAL COMPONENT WAS EXPLANTED BUT IT WAS DECIDED TO LEAVE THE ACETABULAR SHELL IN PLACE. THE ACETABULAR SHELL HAD VISIBLE SMALL SCRATCHES, BUT THE SURFACE SEEMED QUITE SMOOTH. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM.

  Patient problems: Inadequate Osseointegration; Necrosis; Osteolysis

  MAUDE report 16527345 ↗
• InjuryDec 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR HIP RESURFACING SURGERY WAS CONDUCTED ON (B)(6) 2021, THE PATIENT PRESENTED WITH A COLLAPSED HEAD. THE PATIENT HAD EXPERIENCED SOME PAIN OVER THE COURSE OF ROUGHLY 8 MONTHS. DUE TO THIS EVENT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO CORRECT THIS ISSUE. PATIENT IS RECOVERING WELL.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16048518 ↗
• InjuryOct 18, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED IN 2009, A PATIENT WITH A BHR RESURFACING FEMORAL HEAD 48MM STARTED TO EXPERIENCE PAIN ONE YEAR AGO. IT WAS NOTICED THAT THE PATIENT'S METAL IONS WERE IN THE 50 UG/L RANGE. THIS ADVERSE EVENT WAS SOLVED PERFORMING A REVISION SURGERY ON (B)(6) 2022, WHERE THE FEMORAL HEAD WAS REMOVED ALONG WITH EVIDENCE OF PSEUDO TUMOR. THE CUP WAS WELL IMPLANTED AND THUS RETAINED. A HIP STEM WAS IMPLANTED AND THE BDMH WAS UTILIZED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15626173 ↗
• InjuryOct 14, 2022Adverse 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 (B)(6) 2016, THE PATIENT EXPERIENCED MIGRATION AND COLLAPSE OF A BHR RESURFACING FEMORAL HEAD 48MM DUE TO BAD BONE QUALITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A THE FEMORAL HEAD WAS REPLACED WITH A FEMORAL STEM AND A DUAL MOBILITY INSERT. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 15610824 ↗
• InjuryJun 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BHR PERFORMED ON AN UNKNOWN DATE. THE SURGERY FAILED DUE TO UNKNOWN REASONS. THE BHR RESURFACING FEMORAL HEAD 48MM WAS EXPLANTED. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14599401 ↗
• InjuryMay 26, 2022Biocompatibility; Biocompatibility

  *US LEGAL* BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER RIGHT BHR SURGERY WAS PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED PAIN AND ELEVATED ION LEVELS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14516298 ↗
• InjuryMay 26, 2022Biocompatibility; Biocompatibility

  US LEGAL. BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED PAIN AND ELEVATED ION LEVELS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14503640 ↗
• InjuryMay 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON 15-FEB-2012. THE FEMORAL COMPONENT WAS EXPLANTED, AND THE SYSTEM WAS REPLACED WITH A MOM BHR THA. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Pain; Subluxation

  MAUDE report 14436458 ↗
• InjuryMay 19, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER RIGHT BHR SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO OSTEOARTHRITIS, LONG-STANDING RIGHT HIP, AND GROIN PAIN, THE PATIENT EXPERIENCED PAIN AND PROGRESSIVE LIMP. AN MRI IDENTIFIED PRESENCE OF ADVERSE LOCAL TISSUE REACTION AND ELEVATION IN COBALT AND CHROMIUM LEVELS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, IN WHICH SEVERE SYNOVITIS AND DEHISCENCE OF THE ANTEROLATERAL CAPSULAR WAS OBSERVED. REPAIR TO THE TROCHANTER WAS REQUIRED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Infiltration into Tissue; Metal Related Pathology; Pain; Synovitis

  MAUDE report 14435778 ↗

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-0032-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. 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-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. 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.
• Z-0019-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. 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-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. 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-0020-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component.

…and 14 more.