BIRMINGHAM HIP RESURFACING (BHR) 74120150Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 03596010502568), received between May 30, 2017 and Jul 9, 2025 — classified as 58 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT WHO RECEIVED A RIGHT BIRMINGHAM HIP RESURFACING (BHR) SYSTEM ON (B)(6) 2007, EXPERIENCED IMPLANT-RELATED COMPLICATIONS ASSOCIATED WITH ELEVATED METAL ION LEVELS. LABORATORY TESTS SHOWED INCREASED CONCENTRATIONS OF CHROMIUM AND COBALT, INDICATIVE OF POTENTIAL ADVERSE LOCAL TISSUE REACTION (ALTR). A REVISION PROCEDURE WAS REPORTEDLY PERFORMED ON (B)(6) 2017, TO ADDRESS THE CONDITION. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: High metal ion levels; Muscle Weakness/Atrophy

  MAUDE report 22462556 ↗
• InjuryMar 31, 2025Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE (1) ACETLR CUP HAP 50MM W/ IMPTR AND THE (1) BHR MODULAR HEAD 44MM WERE EXPLANTED. IT IS UNKNOWN WHAT OTHER ACTIONS WERE TAKEN TO SOLVE THE PROBLEM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 21731129 ↗
• InjuryJul 9, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR THA SURGERY PERFORMED ON (B)(6) 2007, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 DUE TO METALLOSIS. DURING THE REVISION, A LARGE AREA OF METAL GRANULOMA COMING TO THE SURFACE ADJACENT TO THE TRAILING EDGE OF THE GREATER TROCHANTER WAS FOUND. METAL DEBRIS WERE ALSO FOUND AND ASPIRATED. THERE WAS CONSIDERABLE AMOUNT OF BONE LOSS JUST UNDERNEATH THE FEMORAL COMPONENT. THE STEM OF THE FEMORAL COMPONENT WAS ACTUALLY IDENTIFIED DUE TO THE BONE LOSS. THIS WAS ALL A RESULT OF THE METAL GRANULOMA AND WAS RESPONSIBLE FOR THE ORIGINAL PENCILED APPEARANCE. THE ACETABULUM HAD A DEFECT, THE CUP WAS INTACT. THE CUP WAS REMOVED WITHOUT ANY BONE LOSS, BUT THERE WERE CAVITARY DEFECTS SUPERIORLY AND POSTERIORLY. THE RIM WAS ABSENT, AND THERE WAS ALSO A CAVITY DEFECT INFERIORLY. THE ORIGINAL CUP MEASURED 50 MM, AND WAS EASILY REAMED TO 52MM. THE CUP WAS ALREADY DOWN ON THE QUADRILATERAL PLATE AND EVENTUALLY A 54 MM WAS USED. A 54 MM CUP WITH MULTIPLE DOME SCREWS PROVIDING RIGID FIXATION WAS INSERTED. THE FEMUR WAS EXPOSED AND THE FEMORAL ANTEVERSION MEASURED AT LEAST 50 DEGREES BASED ON THE FIRST RASPS THAT WERE PUT IN PLACE FOR THE SECUR-FIT AND THIS WAS NO

  Patient problems: Metal Related Pathology

  MAUDE report 19707395 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT BHR SURGERY ON (B)(6) 2012, THE PATIENT HAD HIP PAIN, LEG WEAKNESS AND NUMBNESS. DIAGNOSED WITH TROCHANTERIC BURSITIS. PATIENT TREATED WITH MULTIPLE INJECTIONS.

  Patient problems: Bone Fracture(s); Fall; Joint effusion

  MAUDE report 19651195 ↗
• InjuryJun 5, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A PRIMARY BHR LEFT HIP SURGERY ON (B)(6) 2007, THE PATIENT SUFFERED FROM ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2015 IN WHICH THE ACETLR CUP HAP 50MM W/ IMPTR AND RESURFACING FEMORAL HEAD 42MM WERE EXCHANGED FOR A THR SYSTEM. FURTHERMORE, A LARGE CYSTIC DEFECT IN THE SUPERIOR DOME, METALLOSIS TYPE DEBRIS AND DEFECT IN THE ANTERIOR WALL AND THE MEDIAL WALL WERE IDENTIFIED, SO CURETTAGE OF LARGE ACETABULAR BONE CYST AND DEBRIDEMENT OF ACETABULUM WAS NECESSARY, AS WELL AS ACETABULAR RECONSTRUCTION WITH SIGNIFICANT BONE GRAFTING. INTRAOPERATIVE X-RAYS DEMONSTRATED EXCELLENT POSITION OF THE PROTHESIS WITH NO COMPLICATIONS. PATIENT TOLERATED THE PROCEDURE WELL WAS TRANSFERRED OFF THE TABLE ONTO A STRETCHER.

  Patient problems: Metal Related Pathology

  MAUDE report 19468361 ↗
• InjuryJan 19, 2024Biocompatibility; Migration; Biocompatibility; Migration

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED METALLOSIS AND IMPLANT MOBILIZATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENTS STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 18543280 ↗
• InjuryJan 3, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON (B)(6) 2008, A PLAINTIFF UNDERWENT A RIGHT BHMH PROCEDURE, DUE TO AN UNSTABLE SLIPPED SUB CAPITAL FEMORAL EPIPHYSIS. THEN IN 2023 PLAINTIFF COMPLAINED OF WORSENING RIGHT HIP PAIN, DIFFICULTY WITH SINGLE LEG STANCE, GOING UP STAIRS, SQUATTING, AND RIGHT-SIDE WEAKNESS. AN X-RAY FOUND SIGNIFICANT OSTEOLYSIS AROUND THE ACETABULUM AND FEMUR, CONCERNING FOR METALLOSIS; AND LATER BLOOD WORK SHOWED SEVERELY ELEVATED COBALT AND CHROMIUM LEVELS. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. PATIENT'S OUTCOME IS UNKNOWN.

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

  MAUDE report 18437001 ↗
• InjuryOct 13, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PLAINTIFF COMPLAINED OF BILATERAL HIP PAIN, WORSENED IN LEFT HIP, AND DIFFICULTY WITH EVERYDAY ACTIVITIES; THEREFORE, A LEFT PRIMARY BHR WAS CARRIED OUT ON (B)(6) 2013. THEN EVIDENCE OF INCREASED SERUM METAL ION CONCENTRATION WAS FOUND, AND THE PLAINTIFF COMPLAINED OF DYSFUNCTION. A LEFT BHR REVISION WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS EVENT, EVIDENCE OF METALLOSIS WAS NOTICED WITH DARKENED SYNOVIAL TISSUE, AND EROSION POSTERIOR TO THE ACETABULAR SHELL. THE PATIENT WAS IMPLANTED A ZIMMER TOTAL HIP SYSTEM. PATIENT WAS THEN TAKEN TO PACU IN STABLE CONDITION, NO OTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17935094 ↗
• InjuryAug 1, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP BHR RESURFACING PROCEDURE DUE OSTEOARTHRITIS, THE PATIENT EXPERIENCED INCREASING PAIN IN THE LEFT HIP WITH SYSTEMIC MANIFESTATIONS OF METALLOSIS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, A LITTLE BIT OF BLACKENED DEBRIS WAS NOTED. THE ACETABULAR CUP WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15142158 ↗
• InjuryJul 10, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT BHR ON (B)(6) 2008 DUE TO ARTHRITIS. PLAINTIFF IMPLANTS FAILED AND PRESENTED A PSEUDOTUMOR. PLAINTIFF UNDERWENT RIGHT REVISION SURGERY ON (B)(6) 2020 WHERE COMPROMISE AND NECROSIS OF THE POSTERIOR THIRD OF THE G. MEDIUS AND COMPLETE NECROSIS OF THE G. MINIMUS WERE NOTED. THE PSEUDOTUMOR WAS WITHIN THE JOINT AND AROUND THE GREATER TROCHANTERIC BURSA WHICH WAS DEBRIDED. THERE WAS SOME METALLOSIS IN THE SOFT TISSUES OF THE POSTERIOR JOINT CAPSULE. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Metal Related Pathology; Necrosis

  MAUDE report 14973821 ↗
• InjuryApr 13, 2022Biocompatibility; Biocompatibility

  US LEGAL: IT WAS REPORTED THAT, AFTER A LEFT BHR WAS PERFORMED ON (B)(6) 2007 DUE TO LEFT ARTHRITIS, THE PATIENT EXPERIENCED 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

  MAUDE report 14102227 ↗
• InjuryApr 6, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2007, THE PLAINTIFF EXPERIENCED ADVERSE LOCAL TISSUE REACTION ABUTTING THE EXTERNAL ILIAC VESSELS, ELEVATED METAL ION LEVELS, PAIN AND PSEUDOTUMOR FORMATION AROUND THE PELVIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR RESURFACING FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A DUAL MOBILITY LINER ¿ FULL THR SYSTEM. INTRAOPERATIVELY, A DECISION WAS MADE TO RETAIN THE CUP AS THERE WAS NO EVIDENCE OF ANY CORROSION. THE PLAINTIFF WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PLAINTIFF¿S OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14028925 ↗
• InjuryJan 12, 2022Loss of Osseointegration; Biocompatibility; Migration; Loss of Osseointegration; Biocompatibility; Migration

  US LEGAL. IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2019 DUE TO PAIN, ELEVATED METAL ION LEVELS AND SUSPECTED METAL DEBRIS. THE OUTCOME OF THE PATIENT IS UNKNOWN. THE PRIMARY RIGHT BHR SURGERY WAS PERFORMED ON (B)(6) 2009.

  Patient problems: High metal ion levels; Implant Pain; Metal Related Pathology; Osteolysis; Pocket Erosion

  MAUDE report 13242370 ↗
• InjuryOct 26, 2021Biocompatibility; Biocompatibility

  (B)(6). IT WAS REPORTED THAT, AFTER A PRIMARY LEFT BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S HIP ON (B)(6) 2008, THE PLAINTIFF EXPERIENCED ELEVATED LEVELS OF COBALT AND CHROMIUM, METAL STAINING AND THICKENING OF THE SOFT TISSUE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THE SURGERY SOME METAL STAINING OF THE TISSUE AND SOME THICKENING OF THE SOFT TISSUE SUGGESTIVE OF SOME REACTION TO DEBRIS FROM THE METAL BEARING SURFACE WAS FOUND. THE PLAINTIFF¿S OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 12701962 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL - IT WAS REPORTED THAT AFTER A MEDICALLY INDICATED REVISION SURGERY OF THE LEFT HIP PERFORMED ON (B)(6) 2019 (COVER UNDER (B)(6)), PATIENT DEVELOPED A LEFT FOOT DROP WITH INCREASING KNEE PAIN, AND COMPLEX REGIONAL PAIN SYNDROME. CONSERVATIVE TREATMENTS INCLUDING PHYSICAL THERAPY AND PAIN MEDICATION TREATMENT WERE USED TO ADDRESS THE LEFT FOOT DROP, HOWEVER ISSUE PERSISTED. A NERVE DECOMPRESSION AND NEUROPLASTY SURGERY WAS PERFORMED ON (B)(6) 2020, HOWEVER ISSUE PERSISTED, AND SYMPTOMS WORSEN BY PLAINTIFF REPORT. PER LAST REPORT, THE PLAINTIFFS ANKLE IS ROLLING LATERALLY, AND THE WEAKNESS SENSATION HAS INCREASED. PLAINTIFF IS RECEIVING PSYCHIATRIC TREATMENT SINCE DEPRESSION AND ANXIETY WERE REPORTED SECONDARY TO THE MOBILITY ISSUES AND CONSTANT PAIN PLAINTIFF EXPERIENCED. THE LEFT FOOT DROP IS AN OUTGOING ISSUE AND HAS NOT BEEN RESOLVED.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Depression; Muscle Weakness/Atrophy; Neuropathy; Pain

  MAUDE report 12544027 ↗
• InjurySep 28, 2021Biocompatibility; Biocompatibility

  US LEGAL MDL. IT WAS REPORTED THAT AFTER A RIGHT BHR CONSTRUCT WAS IMPLANTED ON (B)(6)2009, PLAINTIFF EXPERIENCED PAIN, LIMITED MOBILITY AND ELEVATED METAL ION LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THESE ADVERSE EVENTS. DETAILS ABOUT THE SURGERY ARE UNKNOWN. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: High metal ion levels; Loss of Range of Motion; Metal Related Pathology; Numbness; Pain

  MAUDE report 12541517 ↗
• InjurySep 1, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR THA CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF'S RIGHT HIP ON (B)(6) 2007, THE PLAINTIFF EXPERIENCED PAIN, ELEVATED METAL LEVELS, METALLOSIS, DIFFICULTY WALKING, LACK OF MOBILITY, GAIT ISSUES AND BACK PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THE REVISION, THE CUP AND STEM WERE WELL FIXED AND WERE LEFT IN PLACE. THE MODULAR HEAD WAS EXPLANTED AND REPLACED WITH A BIOMET DUAL MOBILITY SYSTEM. THE PLAINTIFF'S OUTCOME IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Bursitis; High metal ion levels; Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 12411008 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL MDL* IT WAS REPORTED THAT, 4 WEEKS AFTER THE LEFT HIP RESURFACING PRIMARY SURGERY PERFORMED ON (B)(6) 2008, THE PATIENT STARTED HAVING PAIN, REDNESS, INCREASING ERYTHEMA AND AN UNSPECIFIED INFECTION. THE PATIENT WAS BROUGHT SEMI-URGENTLY TO THE OPERATING ROOM FOR IRRIGATION, DEBRIDEMENT, AND CULTURES OF THE HIP. NO DEVICES WERE EXPLANTED. THE PATIENT WAS AWAKENED AND BROUGHT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THE PATIENT'S INFECTION WAS TREATED WITH THESE PROCEDURES, AS WELL AS WITH THE USE OF A COURSE OF ANTIBIOTICS.

  Patient problems: Erythema; Fluid Discharge; Inflammation; Pain; Unspecified Infection

  MAUDE report 12250101 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO INCREASING OF CR AND CO SERUM IONS. DURING EXPLANT, PERIACETABULAR OSTEOLYSIS AND METALLOSIS WERE OBSERVED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 11643908 ↗
• InjuryApr 6, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT BHR SURGERY PERFORMED ON (B)(6) 2011, THE PATIENT STARTED TO EXPERIENCE PAIN AND SQUEAKING ON THE HIP. ON (B)(6) 2019 IT WAS DETERMINED THAT THE PATIENT HAD ELEVATED COBALT AND CHROMIUM BLOOD LEVELS AND ON (B)(6) 2018 AN MRI DEMONSTRATED THAT THE PATIENT HAD LARGE FLUID COLLECTIONS ON THE HIP AS WELL AS MODERATE DISTAL INSERTIONAL GLUTEUS MINIMUS TENDINOSIS WITH MILD PERITENDINOUS INFLAMMATION. TO TREAT THESE ADVERSE EVENTS, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 IN WHICH THE SYSTEM WAS REPLACED FOR A THA SYSTEM BUT THE ACETLR CUP HAP 50MM W/ IMPTR REMAINED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant; Infiltration into Tissue; Metal Related Pathology; Pain

  MAUDE report 11617753 ↗
• InjuryJan 17, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON THE LEFT HIP ON (B)(6) 2018 AFTER A PRIMARY BHR RESURFACING SYSTEM SURGERY HAD BEEN IMPLANTED ON (B)(6) 2011. THE REVISION SURGERY WAS DUE TO PAIN, LIMITED MOBILITY, METALLOSIS, FLUID UNDER PRESSURE AND/OR PSEUDOTUMOR, AND ¿EXCESSIVELY HIGH¿ ELEVATED METAL ION LEVELS. DURING THIS PROCEDURE, BOTH THE ACETABULAR AND FEMORAL COMPONENTS WERE EXPLANTED AND REPLACED WITH COMPETITORS¿ DEVICES. INTRAOPERATIVELY, A VERY LITTLE METALLOSIS TISSUE WAS DEBRIDED UPON ENTERING THE CAPSULE. TWO LARGE CYSTS WERE IDENTIFIED WITHIN THE ACETABULUM. THE PATIENT WAS AWAKENED AND TRANSPORTED TO THE PACU IN STABLE CONDITION.

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

  MAUDE report 11183276 ↗
• InjuryJan 17, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON THE RIGHT HIP ON (B)(6) 2018 AFTER A PRIMARY BHR RESURFACING SYSTEM SURGERY HAD BEEN IMPLANTED ON (B)(6) 2007. THE REVISION SURGERY WAS DUE TO PAIN, LIMITED MOBILITY, METALLOSIS, FLUID UNDER PRESSURE AND/OR PSEUDOTUMOR, ¿EXCESSIVELY HIGH¿ ELEVATED METAL ION LEVELS AND A SUSTAINED FEMORAL NECK STRESS FRACTURE. DURING THIS PROCEDURE, BOTH THE ACETABULAR AND FEMORAL COMPONENTS WERE EXPLANTED AND REPLACED WITH COMPETITORS¿ DEVICES. INTRAOPERATIVELY, A SIGNIFICANT AMOUNT OF METALLOSIS-TYPE TISSUE WAS PRESENT WITHIN THE JOINT INVOLVING THE ENTIRE SYNOVIUM, BELOW THE LESSER TROCHANTER AND DEEP TO THE ACETABULAR. THE PATIENT WAS AWAKENED FROM SEDATION AND TRANSPORTED TO THE PACU IN STABLE CONDITION.

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

  MAUDE report 11183246 ↗
• InjuryJan 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON THE RIGHT HIP, AFTER A PRIMARY BHR RESURFACING SYSTEM SURGERY, DUE TO PAIN, LIMITED MOBILITY AND ELEVATED METAL ION LEVELS. ONLY THE HEAD WAS EXPLANTED, A NEW LINER, HEAD AND STEM WAS IMPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

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

  MAUDE report 11183207 ↗
• InjuryDec 16, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER A RIGHT BHR SYSTEM HAD BEEN IMPLANTED ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED UNEXPLAINED PAIN, SIGNIFICANTLY ELEVATED CHROMIUM AND COBALT LEVELS AND PSEUDOTUMOR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO ADDRESS THIS EVENT. THE INTRAOPERATIVE FINDINGS WERE: LARGE AMOUNT OF NECROTIC MATERIAL IN THE HIP FROM THE PSEUDOTUMOR, AS WELL AS ADDITIONAL NECROTIC DEBRIS AND METALLIC DEBRIS, CONSISTENT WITH METAL ON METAL WEAR FROM A FAILED RIGHT HIP RESURFACING ARTHROPLASTY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Cyst(s); Failure of Implant; Metal Related Pathology; Necrosis; Pain

  MAUDE report 11023330 ↗
• InjuryNov 27, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY WAS PERFORMED ON THE HIP DUE TO IMPENDING FRACTURE FEMORAL NECK ON RESURFACING BHR PROSTHESIS RIGHT SIDE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 10913544 ↗

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-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-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-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. 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-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. 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-0021-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. 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.
• Z-0020-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. 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-0026-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component.

…and 14 more.