BIRMINGHAM HIP RESURFACING (BHR) 74120148Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 03596010502551), received between Jan 5, 2017 and Jun 10, 2025 — classified as 1 death, 55 injuries.

The most frequently reported specific device problem is “Biocompatibility” (19 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2008 AND DEVELOPED A METALLOSIS, ELEVATED METAL LEVELS WERE NOTICED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. EXTENSIVE METALLOSIS STAINING WAS NOTED THROUGHOUT DEEP CAPSULE. THE CUP AND FEMORAL HEAD WERE REMOVED. COMPETITOR DEVICES WERE IMPLANTED. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Metal Related Pathology

  MAUDE report 22176050 ↗
• InjuryMay 5, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR IN HIS RIGHT HIP JOINT ON (B)(6) 2008, PATIENT EXPERIENCED DISCOMFORT AS WELL AS ELEVATED METAL ION LEVELS. PHYSICAL EXAM AND RADIOGRAPHS WERE CONSISTENT WITH A METAL-ON-METAL RIGHT HIP RESURFACING WITH SOME EVIDENCE OF OSTEOLYSIS OR NARROWING OF HER FEMORAL NECK. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2022, DURING WHICH, SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY. DURING PROCEDURE, THERE WAS NOTED TO BE METAL STAINING THROUGHOUT THIS AREA AND THIS WAS SAMPLED NOT ONLY FOR CULTURES, BUT FOR PATHOLOGIC ANALYSIS. INTRAOPERATIVELY, PATIENT RECEIVED A LITER OF CRYSTALLOID FLUID. THERE WERE NO COMPLICATIONS.

  Patient problems: Metal Related Pathology

  MAUDE report 21964489 ↗
• InjuryJul 8, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, PATIENT UNDERWENT A LEFT BHR-THA SURGERY ON (B)(6) 2008 USING S+N BHR COMPONENTS AND A COMPETITOR STEM AND NECK. ANNUAL CHECKUPS AND X-RAYS FROM (B)(6) 2008 TO (B)(6) 2013 DID NOT REVEAL ISSUES. IN 2014 ANNUAL CHECKUPS FOR METAL IONS WERE INCLUDED. ON (B)(6) 2018 AN MRI SHOWED A MULTI-LOBED FORMATION; THEREFORE, THE PATIENT WAS SCHEDULE FOR REVISION SURGERY IN (B)(6) 2018, BUT THE SURGERY WAS POSTPONED. THE PATIENT CONTINUED FOLLOW UPS FOR MONITORING THE MOM PROSTHESIS AND IN (B)(6) 2019 A NEEDLE ASPIRATION WAS PERFORMED, WHICH EXCLUDED THE PRESENCE OF INFECTIOUS PATHOLOGIES. THEN, IN (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY, DURING WHICH ABUNDANT BROWNISH LIQUID WITH METALLOSIS WAS FOUND AND BOTH ACETABULAR AND FEMORAL BHR COMPONENTS WERE EXCHANGED FOR COMPETITOR DEVICES. PATIENT WAS DISCHARGED ON (B)(6) 2020. POST SURGERY BLOOD TESTS REVEALED A DECREASE IN CHROMIUM COBALT ION LEVELS. FURTHER COMPLICATIONS WERE NOT REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 19697908 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "BIRMINGHAM HIP RESURFACING FOR OSTEOARTHRITIS ¿ A CANADIAN RETROSPECTIVE COHORT STUDY WITH A MINIMUM 10-YEAR FOLLOW-UP", AFTER A BHR RESURFACING SURGERY PERFORMED DUE TO OSTEOARTHRITIS, PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY 78 MONTHS AFTER IMPLANTATION. A CONVERSION FROM BHR RESURFACING TO A BHR THA WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16820439 ↗
• InjuryOct 26, 2022Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A BIRMINGHAM HIP MODULAR HEAD SYSTEM HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON 03-DEC-2008, THE PATIENT SUFFERED FROM METAL DEBRIS INFILTRATION IN THE HIP JOINT, SURROUNDING TISSUE AND THE BLOODSTREAM. THE ISSUE RESULTED IN A CATASTROPHIC FAILURE OF THE RIGHT HIP, WHICH LED TO 2 REVISION SURGERIES TO REPAIR THE EXTENSIVE DAMAGE OF THE PELVIS. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Hematoma; High metal ion levels; Inadequate Osseointegration; Joint Dislocation; Metal Related Pathology

  MAUDE report 15674249 ↗
• InjuryAug 3, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING LEFT HIP BHR RESURFACING SURGERY, AFTER PLACING A 48MM BHR ACETABULAR CUP, WHEN PULLING OUT THE CABLE WITH THE POLYETHYLENE IMPACTOR, IT GOT CAUGHT AND DISLODGED THE CUP AFTER THE CABLE HAD ALREADY BEEN CUT. THE SURGEON TRIED TO RE-IMPACT THE CUP, HOWEVER, IT FAILED TO BE REPOSITIONED. THE 48MM BHR ACETABULAR CUP WAS REMOVED AND THE PROCEDURE WAS FINISHED USING A 50MM BHR ACETABULAR CUP AFTER REAMING WAS PERFORMED UP TO SIZE 49. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15161199 ↗
• InjuryJul 27, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BIRMINGHAM HIP RESURFACING PROCEDURE ON (B)(6) 2006 DUE TO OSTEOARTHRITIS IN THE RIGHT HIP, THE PATIENT UNDERWENT A REVISION SURGERY TO A TOTAL HIP ARTHROPLASTY ON (B)(6) 2022. THE ACETABULAR CUP AND THE FEMORAL HEAD WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 15117129 ↗
• InjuryJul 11, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A REVISION SURGERY PERFORMED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2017 DUE TO ELEVATED METAL ION LEVELS, PAIN AND PSEUDOTUMOR FORMATION, THE PATIENT EXPERIENCED MULTIPLE DISLOCATIONS AND REQUIRED AN ADDITIONAL REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE BHR ACETABULAR CUP WAS EXPLANTED WITH THE REST OF THE BEARING COMPONENTS (COMPETITORS) AND REPLACED WITH A NEW SHELL, A CONSTRAINED LINER AND A FEMORAL HEAD. INTRAOPERATIVELY, SEVERE PLASTIC WEAR FROM THE DISLOCATED DUAL MOBILITY LINER WAS IDENTIFIED AND A DEEP SUBFASCIAL PSEUDOTUMOR WAS EXCISED. THE PATIENT¿S OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 14974283 ↗
• InjuryJun 11, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED OSTEOLYSIS AROUND HER PELVIS AND LOOSENING OF THE ACETABULAR COMPONENT FOLLOWING A METALLOSIS DIAGNOSIS. A REVISION SURGERY WAS PERFORMED ON 20-SEP-2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE POSTERIOR HIP CAPSULE HAD STAINING CONSISTENT WITH A GRAY METALLOSIS, AND THE JOINT PRESENTED SOME GRAYISH FLUID AND SIGNIFICANT GRAY AND BLACK STAINING TO THE SOFT TISSUE. SOME OSTEOLYSIS ALONG THE POSTERIOR FEMORAL SHAFT IN THE METAPHYSEAL REGION WAS ALSO NOTED. UPON REMOVING THE BHR MODULAR FEMORAL HEAD AND CUP, THE SURGEON FACED SEVERAL DIFFICULTIES WHILST FIXING A 56MM ACETABULAR CUP AND WAS NOT SATISFIED WITH THE OUTCOME, AS A PROPERLY FIXATION COULD HAD BEEN COMPROMISED MAINLY DUE TO THE DEFICIENT CONDITION OF THE MEDIAL, ANTERIOR AND POSTERIOR WALL OF THE ACETABULUM. BECAUSE OF THIS, HE DECIDED TO PLACE THE NEW IMPLANTS AND CLOSE THE INCISION TO FURTHER PLAN A CAGED RECONSTRUCTION OF THE ACETABULUM. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14670344 ↗
• InjuryJun 8, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT BHR-THA SURGERY WAS PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN AT THE HIP JOINT AND ELEVATED COBALT AND CHROMIUM LEVELS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE BHR MODULAR HEAD WAS REMOVED FROM THE SYSTEM AND REPLACED WITH A SMITH AND NEPHEW DUAL MOBILITY LINER AND A 28MM +4 OXINIUM HEAD. INTRAOPERATIVELY, THE ACETABULAR COMPONENT WAS NOTED TO BE IN GOOD POSITION AND WITHOUT ANY EVIDENCE OF LOOSENING. THE TRUNNION PRESENTED A SMALL AMOUNT OF CORROSION IN THE MID DISTAL REGION BUT WAS OVERALL IN GOOD SHAPE. THE PATIENT WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT WITHOUT ANY COMPLICATIONS.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14633971 ↗
• InjuryMay 29, 2022Biocompatibility; Biocompatibility

  US LEGAL. BILATERAL PATIENT. IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A LEFT HIP REVISION SURGERY ON (B)(6) 2021 DUE TO COBALT TOXICITY AND FAILED THA. DURING THE REVISION SURGERY, THE FEMORAL HEAD AND NECK WERE EXPLANTED AND REPLACED WITH A PLASTIC INSERT AND AN OXINIUM FEMORAL HEAD. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THE PRIMARY BHR THA PROCEDURE WAS PERFORMED ON (B)(6) 2009.

  Patient problems: Metal Related Pathology

  MAUDE report 14539033 ↗
• InjuryApr 5, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED PAIN, WEAKNESS, TRENDELENBURG GAIT, ELEVATED CHROMIUM AND COBALT ION LEVELS IN BLOOD AND FLUID WITH INFLAMMATION OF THE CAPSULE DUE TO ADVERSE REACTION TO METAL DEBRIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE RESURFACING FEMORAL HEAD 42M WAS REMOVED AND REPLACED WITH A TOTAL HIP ARTHROPLASTY CONSTRUCT. THE BHR ACETABULAR CUP WAS WELL FIXED AND POSITIONED ON THE PATIENT¿S ACETABULUM; THEREFORE, IT WAS NOT EXPLANTED. THE PATIENT WAS TRANSFERRED TO THE PACU ROOM IN STABLE CONDITION.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Metal Related Pathology

  MAUDE report 14007953 ↗
• InjuryApr 5, 2022Biocompatibility; Biocompatibility

  *US LEGAL MDL* IT WAS REPORTED THAT, AFTER PRIMARY LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED PAIN AND METALLOSIS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2020. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14007765 ↗
• InjuryMar 31, 2022Biocompatibility; Biocompatibility

  (B)(6). BILATERAL PATIENT. IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A LEFT HIP REVISION SURGERY ON (B)(6) 2019 DUE TO PAIN, ELEVATED CHROMIUM AND COBALT LEVELS, OSTEOLYSIS, FLUID COLLECTION, AND REACTIVE TISSUE AROUND THE SHELL. THIS PATIENT HAD ALREADY HAD A BHR REVISION SURGERY OF THE RIGHT HIP ON 2018 DUE TO A SIMILAR COMPLICATION. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 13965621 ↗
• InjuryMar 23, 2022Biocompatibility; Biocompatibility

  US LEGAL IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2021 DUE TO PAIN, LIMITED MOBILITY, AND ELEVATED METAL ION LEVELS. THE PRIMARY LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2008. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Infiltration into Tissue; Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 13864856 ↗
• DeathDec 27, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT BHR IN (B)(6) 2007 DUE TO OSTEOARTHRITIS, THE PATIENT PRESENTED FLUID ACCUMULATION IN THE CAPSULE OF THE RIGHT ANTERIOR JOINT THAT COMMUNICATES WITH THE ILIOPSOAS BURSA, THIS WAS DIAGNOSED BY AN MRI ON (B)(6) 2021, THE PATIENT ALSO PRESENTED ELEVATED METAL IONS, RELATED TO AN ASEPTIC LYMPHOCYTE-DOMINANT VASCULITIS-ASSOCIATED LESION (ALVAL). A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 AFTER PATIENT HAD A CVA WITH DYSPHASIA AND WEAKNESS DOWN THE RIGHT-HAND SIDE BOTH ARM AND LEG. PATIENT INITIALLY WAS ADMITTED AND TREATED FOR ST ELEVATION MYOCARDIAL INFARCTION AND ISCHEMIC LEFT MCA STROKE; ALSO, IT WAS DIAGNOSED WITH STAPH AUREUS BACTEREMIA. AFTER THE REVISION SURGERY WAS PERFORMED WITH A HIP WASHOUT AND REMOVAL OF COMPONENTS, PATIENT HAD FURTHER DETERIORATION IN THE ICU AND PASSED AWAY ON (B)(6) 2021.

  Patient problems: Bacterial Infection; Failure of Implant; Ischemia Stroke; Metal Related Pathology; Myocardial Infarction; Sepsis; Septic Shock; Toxemia

  MAUDE report 13090506 ↗
• InjuryNov 9, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT BIRMINGHAM HIP RESURFACING HAD BEEN PERFORMED ON (B)(6) 2011, PLAINTIFF HAS EXPERIENCED HIP PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 AND IT WAS CONVERTED TO A THA. DURING THE SURGERY IT WAS FOUND METALLOSIS AND IT WAS DONE A RESORPTION OF THE FEMORAL NECK. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s); Metal Related Pathology; Pain

  MAUDE report 12778570 ↗
• InjuryOct 22, 2021Biocompatibility; Biocompatibility

  US LEGAL, IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A SECOND REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2019 DUE A METAL RELATED PATHOLOGY. DURING THE SURGERY, EVIDENCE OF SIGNIFICANT OSTEOLYSIS AND METALOSIS WAS FOUND, AND THE METALLIC CUP AND FEMORAL HEAD WERE EXPLANTED. AFTER THE REVISION, THE PATIENT WAS DIAGNOSED WITH ¿COBALT CARDIOMYOPATHY¿ AND SUFFERED SEVERE COMPLICATIONS RELATED TO PROGRESSIVE CARDIOGENIC SHOCK, ACUTE RENAL FAILURE WITH HYPERKALEMIA, HYPONATREMIA, AND METABOLIC ACIDOSIS. THIS ISSUE HAS NOT BEEN RESOLVED.

  Patient problems: Metal Related Pathology

  MAUDE report 12681745 ↗
• InjurySep 30, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, IT WAS FOUND A METALLOSES RESULTING FROM METAL-METAL HIP PROSTHESIS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 12555728 ↗
• InjurySep 22, 2021Biocompatibility; Biocompatibility

  (B)(6) LEGAL. IT WAS REPORTED THAT AFTER A LEFT BHR THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2006, THE PLAINTIFF EXPERIENCED ELEVATED ION LEVELS ON BLOOD, AND LOBULATED-LIKE-MASS AROUND THE IMPLANTS THE LEFT HIP CONSISTENT WITH PSEUDOTUMOR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY BROWNISH LIQUID, NECROTIC TISSUE AND TRUNNIONS WERE FOUND. ADDITIONALLY, SIGNIFICANT CORROSION AT THE JUNCTION OF THE HEAD AND THE FEMORAL NECK WAS ALSO FOUND. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Necrosis

  MAUDE report 12516677 ↗
• InjurySep 9, 2021Biocompatibility; Biocompatibility

  US LEGAL MDL. IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2010, THE PLAINTIFF EXPERIENCED ELEVATED METAL ION LEVELS, PAIN, A LATERAL FLUID COLLECTION AND PSEUDOTUMOR FORMATION ALONG THE POSTERIOR CAPSULE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

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

  MAUDE report 12446700 ↗
• InjuryJul 12, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A BHR SURGERY WAS PERFORMED ON (B)(6) 2008, A REVISION SURGERY HAD TO BE CONDUCTED ON (B)(6) 2021 DUE TO METAL ON METAL PAIN. A MODULAR SLEEVE +8MM 12/14, A HEMI HEAD 42MM, AND A ACETLR CUP HAP 48MM W/ IMPTR WERE EXPLANTED. PATIENT OUTCOME REMAINS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 12150366 ↗
• InjuryMay 11, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT, AFTER A LEFT BHR CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2011, THE PLAINTIFF EXPERIENCED PAIN, LIMITED MOBILITY, ADVERSE LOCAL TISSUE REACTION AND THE FOLLOWING METAL ION BLOOD LEVELS: COBALT (13.3 G/L) AND CHROMIUM (23.2 G/L). A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. THE REVISION OPERATIVE REPORT INDICATED THE PRESENCE OF SYNOVITIS AND WELL-FIXED COMPONENTS THAT WERE REMOVED AND REPLACED WITH ANOTHER MANUFACTURER¿S DEVICES. THE PLAINTIFF OUTCOME IS UNKNOWN.

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

  MAUDE report 11805873 ↗
• InjuryMay 6, 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 DUE TO PATIENT HAD PAINFUL LEFT HIP AFTER PRIMARY IMPLANTATION. THE MODULAR HEAD 42 MM -4 (SHORT) AND THE ACETLR CUP HAP 48MM W/ IMPTR WERE REMOVED. THE SYNERGY 12 STD OFFSET STEM WAS LEFT INSITU. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11787127 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER BHR IMPLANT SURGERY PERFORMED IN (B)(6) 2003, DUE TO SEVERE PAIN, A REVISION SURGERY WAS PERFORMED IN (B)(6) 2011, THERE IS A DIAGNOSIS FOR METALLOSIS, AND THERE IS STILL A LOT OF PAIN, AND RESPIRATORY ISSUES REPORTED, PATIENT IS WAITING FOR ANOTHER SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Metal Related Pathology; Pain; Respiratory Insufficiency

  MAUDE report 11462009 ↗

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-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-2267-2018 · May 11, 2018 · Terminated
  Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
• 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-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-0020-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. 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-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. 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.
• Z-0029-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0028-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. 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-0027-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component.

…and 14 more.