BIRMINGHAM HIP RESURFACING (BHR) 74121146Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 03596010502780), received between Jul 20, 2017 and Nov 7, 2025 — classified as 91 injuries.

The most frequently reported specific device problem is “Biocompatibility” (46 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 91 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING A BHR ON (B)(6) 2010 DUE TO DEGENERATIVE ARTHRITIS OF THE RIGHT HIP, THE PATIENT SUFFERED FROM A FAILED RIGHT HIP RESURFACING BECAUSE SHE HAS HAD PROGRESSIVE PAIN, ELEVATED METAL IONS, AND LOOSENING OF ACETABULAR COMPONENT. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH THE WHOLE HIP SYSTEM WAS EXPLANTED. DURING PROCEDURE, AN ANTERIOR CAPSULECTOMY WAS PERFORMED. UPON ENTERING THE JOINT, THERE WAS NO OBVIOUS INFECTION OR PURULENCE. THE FINAL FEMORAL COMPONENT WAS NOW IMPACTED, USING GREAT CARE TO EVALUATE THE CALCAR, WHICH REMAINED STABLE DURING IMPACTION, NO VISUAL DEFECTS OCCURRED; FLUOROSCOPIC IMAGES CONFIRMED THIS. THE PATIENT WAS AWOKEN AND SENT TO THE POST-ANESTHESIA CARE UNIT IN STABLE CONDITION.

  Patient problems: Abnormal scarring; High metal ion levels; Joint Laxity; Pain

  MAUDE report 23501105 ↗
• InjuryNov 4, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR ON (B)(6) 2012 DUE TO DEGENERATIVE ARTHRITIS OF THE LEFT HIP, THE PATIENT EXPERIENCED A FAILED LEFT HIP RESURFACING CHARACTERIZED BY PROGRESSIVE PAIN, ELEVATED METAL ION LEVELS, AND LOOSENING OF THE ACETABULAR COMPONENT. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON 2025, DURING WHICH THE ENTIRE HIP SYSTEM WAS EXPLANTED. DURING THE PROCEDURE, AN ANTERIOR CAPSULECTOMY WAS PERFORMED, AND UPON ENTERING THE JOINT, NO SIGNS OF INFECTION OR PURULENCE WERE OBSERVED. THE FINAL FEMORAL COMPONENT WAS IMPACTED WITH GREAT CARE TO EVALUATE THE CALCAR, WHICH REMAINED STABLE DURING IMPACTION, WITH NO VISUAL DEFECTS NOTED; FLUOROSCOPIC IMAGES CONFIRMED STABILITY. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT IN STABLE CONDITION.

  Patient problems: Deformity/ Disfigurement; High metal ion levels; Pain

  MAUDE report 23461624 ↗
• InjuryOct 6, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT BHR ON (B)(6) 2010 DUE TO OSTEOARTHRITIS, IN 2015 EXPERIENCED PAIN DURING RUNNING AND WHEN LYING ON HIS LEFT SIDE, BUT EVERYTHING SEEMED FINE IN HIS X-RAYS. AFTER THIS, THE PAIN IN THE LEFT HIP INCREASED AND MRI SHOWED A SMALL FLUID COLLECTION AND A TEAR OF THE GLUTEUS MEDIUS. COBALT AND CHROMIUM IONS WERE ALSO ELEVATED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO A FAILED BHR WITH METALLOSIS. THE FEMORAL HEAD WAS EXPLANTED AND REPLACED FOR ZIMMER DUAL MOBILITY LINER, BIOMET BIOLOX DELTA CERAMIC FEMORAL HEAD AND TAPERLOC REDUCED DISTAL FEMORAL STEM. THE BHR CUP WAS RETAINED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology; Muscle/Tendon Damage

  MAUDE report 23230531 ↗
• InjuryJul 8, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A BHR SYSTEM IN THE LEFT HIP ON (B)(6) 2010 DUE TO COXARTHROSIS. THE PATIENT HAD AN ASPIRATION THAT REMOVED APPROXIMATELY 20CC OF FLUID AND BROWNISH CONTENT. THE PATIENT UNDERWENT A REVISION SURGERY ON THE (B)(6) 2025, IN WHICH A PSEUDOTUMOR WAS REMOVED AND THE FEMORAL HEAD REPLACED, WHILE THE ACETABULAR CUP WAS RETAINED. THE PATIENT RECEIVED A DUAL MOBILITY SYSTEM. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 22437282 ↗
• InjuryMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR IN HIS LEFT HIP JOINT ON (B)(6) 2008, PATIENT EXPERIENCED LEFT FEMORAL NECK FRACTURE BELOW HIP RESURFACING. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2008, DURING WHICH, SURGEON CONVERTED TO BHR-THA. DURING PROCEDURE, THE FEMORAL HEAD WAS FOUND TO HAVE COMPLETED FRACTURED OFF OF THE NECK AND THERE WAS A NECK FRACTURE EXTENDING ALONG THE CALCAR ALMOST TO THE LESSER TROCHANTER, HOWEVER, IT DID END THERE AND THERE WAS GOOD SOLID BONE REMAINING. ONCE THE FEMORAL HEAD HAD BEEN REMOVED, THE FEMORAL NECK WAS REMOVED WITH AN OSCILLATING SAW. HE WAS TRANSPORTED TO HIS BED AND TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Periprosthetic fracture

  MAUDE report 22026864 ↗
• InjuryMay 15, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2009, HE HAS EXPERIENCED ISSUES WHICH LIMIT HIS MOVEMENTS AND FUNCTION, AS WELL AS IT IS VERY PAINFUL FOR HIM. SEEMS LIKE IT COULD BE BROKEN. THE OPERATIVE FINDINGS SHOWED MODEST METAL REACTION AND IMPINGEMENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE FEMORAL HEAD WAS EXPLANTED AND ACETABULAR COMPONENT WAS RETAINED. COMPETITOR IMPLANTS WERE USED A S REPLACEMENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Impingement; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 22023823 ↗
• InjuryApr 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER BHR SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE (1) RESURFACING FEMORAL HEAD 46MM HAD BECOME LOOSE. THIS ADVERSE EVENT WAS SOLVED/TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE RESURFACING FEMORAL HEAD 46MM WAS REMOVED AND A POLARSTEM WITH A BHDM HEAD WAS IMPLANTED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 21926969 ↗
• InjuryMar 19, 2025Adverse 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 AT 25 YEARS", ONE (1) PATIENT AFTER A BHR HIP RESURFACING PROCEDURE, SUFFERED A PERIPROSTHETIC FEMORAL NECK FRACTURE 19 YEARS POST-SURGERY. PATIENT REQUIRED REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Periprosthetic fracture

  MAUDE report 21646331 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR RESURFACING IN HIS LEFT HIP JOINT ON (B)(6) 2007, THE PATIENT SUSTAINED A LEFT FEMORAL NECK FRACTURE THAT REQUIRED A CONVERSION TO THA ON (B)(6) 2007. THE RESULTING SYSTEM INCLUDED A TRADITIONAL FEMORAL STEM, BHR CUP, AND MODULAR COBALT-CHROMIUM FEMORAL HEAD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Periprosthetic fracture

  MAUDE report 20733886 ↗
• InjuryNov 11, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR ON (B)(6) 2007, DUE TO DEGENERATIVE JOINT DISEASE ON RIGHT HIP. IN ADDITION, PATIENT HAD SEVERE DEGENERATIVE JOINT DISEASE ANTEROSUPERIOR FEMORAL HEAD AND CORRESPONDING AREA ON THE ACETABULUM. SHE HAD A LABRAL TEAR THAT NOT INVERTED. AFTER THIS, PATIENT SUFFERED FROM ADVERSE LOCAL TISSUE RESPONSE WITH COMPLETE DESTRUCTION OF THE POSTERIOR EXTERNAL ROTATORS AND CAPSULE CONSISTENT WITH LARGE METAL-ON-METAL HIP RESURFACING. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE RESURFACING FEMORAL HEAD 46MM WAS EXPLANTED. DURING PROCEDURE, UPON INCISING THE FASCIA IT WAS CLEAR THAT THE PATIENT HAD ADVERSE LOCAL TISSUE RESPONSE INVOLVING THE ENTIRE SHORT EXTERNAL ROTATORS AND CAPSULE. SURGEON EVALUATED THE ACETABULAR COMPONENT. IT WAS WELL-FIXED, MEDIAL, OVERSIZED, GOOD INCLINATION, AND SLIGHTLY DECREASED ANTEVERSION. HOWEVER, GIVEN THE PROS PREVIOUSLY LISTED, OPTED TO MAINTAIN IT. HE DID NOT THINK IT WAS POSSIBLE TO CLOSE THE SHORT EXTERNAL ROTATORS AS THE SCIATIC NERVE WAS VERY CLOSE TO THE PREVIOUSLY TAGGED SUTURE. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS.

  Patient problems: Metal Related Pathology

  MAUDE report 20653123 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "CLINICAL AND RADIOGRAPHIC OUTCOMES OF THE BIRMINGHAM HIP RESURFACING ARTHROPLASTY AT A MINIMUM FOLLOW-UP OF 10 YEARS: RESULTS FROM AN INDEPENDENT CENTRE", 1 (ONE) PATIENT SUFFERED FROM A NECK FEMORAL FRACTURE AND REQUIRED A REVISION SURGERY 5 MONTHS AFTER THE PRIMARY METAL-ON-METAL HIP RESURFACING PROCEDURE. DURING THE REVISION SURGERY, THE PRIMARY FEMORAL COMPONENT WAS EXPLANTED AND REPLACED BY AN UNSPECIFIED UNCEMENTED THA METAL-ON-METAL STEM. THE PRIMARY SURGERY WAS A BHR METAL ON METAL DUE TO OSTEOARTHRITIS. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Failure of Implant; Hip Fracture

  MAUDE report 19706615 ↗
• InjuryJul 9, 2024Biocompatibility; Migration; Biocompatibility; Migration

  IT WAS REPORTED THAT ON LITERATURE REVIEW ""CLINICAL AND RADIOGRAPHIC OUTCOMES OF THE BIRMINGHAM HIP RESURFACING ARTHROPLASTY AT A MINIMUM FOLLOW-UP OF 10 YEARS: RESULTS FROM AN INDEPENDENT CENTRE"", 1 (ONE) PATIENT SUFFERED FROM A VARUS FEMORAL COMPONENT SHIFT AND REQUIRED A REVISION SURGERY 72 MONTHS AFTER THE PRIMARY METAL-ON-METAL HIP RESURFACING PROCEDURE. DURING THE REVISION SURGERY, THE PRIMARY SYSTEM WAS EXPLANTED AND REPLACED BY AN UNSPECIFIED UNCEMENTED THA METAL-ON-POLYETHILENE SYSTEM. THIS PATIENT PRESENTED METAL ION LEVELS IN BLOOD OF CO = 5.42 NG/ML AND CR = 3.03 NG/ML BEFORE REVISION AND CO = 1.58 NG/ML AND CR = 1.24 NG/ML AFTER REVISION. THE PRIMARY SURGERY WAS A BHR METAL ON METAL DUE TO OSTEOARTHRITIS. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: High metal ion levels

  MAUDE report 19706609 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "CLINICAL AND RADIOGRAPHIC OUTCOMES OF THE BIRMINGHAM HIP RESURFACING ARTHROPLASTY AT A MINIMUM FOLLOW-UP OF 10 YEARS: RESULTS FROM AN INDEPENDENT CENTRE", 1 (ONE) PATIENT SUFFERED FROM A NECK FEMORAL FRACTURE AND REQUIRED A REVISION SURGERY 88.6 MONTHS AFTER THE PRIMARY METAL-ON-METAL HIP RESURFACING PROCEDURE. DURING THE REVISION SURGERY, THE PRIMARY SYSTEM WAS EXPLANTED AND REPLACED BY AN UNSPECIFIED UNCEMENTED THA CERAMIC-ON-CERAMIC SYSTEM. THE PRIMARY SURGERY WAS A BHR METAL ON METAL DUE TO OSTEOARTHRITIS IN CONGENITAL HIP DYSPLASIA. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Failure of Implant; Hip Fracture

  MAUDE report 19705896 ↗
• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR SURGERY WAS PERFORMED ON THE (B)(6)2009, THE PATIENT UNDERWENT A REVISION SURGERY ON THE (B)(6)2023 WERE THE BHR SYSTEM WAS CONVERTED TO A THA.

  Patient problems: Insufficient Information

  MAUDE report 19675068 ↗
• InjuryMay 24, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PATIENT UNDERWENT A RIGHT BHR PROCEDURE ON (B)(6) 2011. THE PATIEN LATER STARTED EXPERIENCING PROGRESSIVE PAIN AND LIMITED INTERNAL ROTATION OF THE HIP; RADIOGRAPHS SHOWED NOTCHING OF THE ANTERIOR SUPERIOR FEMORAL NECK FROM THE METAL ACETABULAR SHELL, AND THE PATIENT ALSO TESTED FOR MINIMALLY ELEVATED CHROMIUM AND COBALT LEVELS. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING SURGERY BROWN COLORED WEAR DEBRIS WAS FOUND, THE SHELL WAS ELECTED TO BE KEPT IN PLACE, AND A ZIMMER STEM AND CERAMIC POLYETHYLENE HEAD WERE IMPLANTED. FURTHER COMPLICATIONS WERE NOT REPORTED.

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

  MAUDE report 19391917 ↗
• InjuryFeb 8, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY BHR RESURFACING LEFT HIP DUE TO OSTEOARTHRITIS SURGERY ON (B)(6) 2012 AND SUBSEQUENTLY SUFFERED FROM FAILED RESURFACING HIP ARTHROPLASTY. AN MRI WAS SUGGESTIVE OF ADVERSE LOCAL TISSUE REACTION ASSOCIATED WITH CORROSION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2023 TO EXPLANT THE RESURFACING FEMORAL HEAD 46MM. THE ACETABULAR CUP WAS RETAINED AS THERE WAS NO CORROSION AND WAS WELL FIXED. DURING THIS PROCEDURE ANY NECROTIC OR FIBRINOUS TISSUE WAS DEBRIDED DOWN TO HEALTHY BLEEDING TISSUE AND BONE CIRCUMFERENTIALLY AROUND THE FEMUR AND ACETABULUM. THERE WAS IMMEDIATE RUSH OF GREY TINGED SEROUS FLUID IN THE JOINT AND IT EXTENDED INTO THE SOFT TISSUES SURROUNDING THE JOINT AS DEMONSTRATED CONSISTENT WITH THE MRI. PATIENT WAS DONE AN EXCISIONAL DEBRIDEMENT AND IRRIGATION DOWN TO BONE AND FASCIA. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 18671024 ↗
• InjuryAug 4, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP RESURFACING (BHR) ON (B)(6) 2011 DUE TO ADVANCED OSTEOARTHRITIS AND PROGRESSIVE HIP PAIN, THE PATIENT SUFFERED METALLOSIS. THIS COMPLICATION WAS TREATED BY CONDUCTING A REVISION SURGERY COMBINED WITH EXTENSIVE SYNOVECTOMY AND DEBRIDEMENT ON (B)(6) 2023. DURING THIS PROCEDURE, THE BHR COMPONENTS WERE OBSERVED TO BE WELL-FIXED. HOWEVER, BLACK STAINING SYNOVIAL TISSUE, SMALL PSEUDOTUMORS AND FOREIGN BODY REACTION WERE NOTICED TO BE CONSISTENT WITH METALLOSIS. HIP RESURFACING IMPLANTS WERE REMOVED AND REPLACED WITH A COMPETITOR¿S THA SYSTEM (STRYKER). THE PATIENT WAS TRANSFERRED TO RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Foreign Body Reaction; High metal ion levels; Metal Related Pathology

  MAUDE report 17466781 ↗
• InjuryJun 5, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING SYSTEM LEFT HIP CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2008, THE PLAINTIFF REPORTED PAIN AND LACK OF MOBILITY. THIS IS A BILATERAL PATIENT, AND A REVISION SURGERY OF THE RIGHT HIP WAS PERFORMED ON (B)(6) 2020 (COVERED UNDER (B)(4) DUE TO A METAL RELATED PATHOLOGY. EVEN THOUGH A REVISION SURGERY OF THE LEFT HIP HAS NOT BEEN PERFORMED OR SCHEDULED, THE CONTRIBUTION OF THE LEFT HIP CONSTRUCT CAN NOT BE DISCARDED AS A CONTRIBUTOR OF THE ELEVATED COBALT AND CHROMIUM LEVELS IN BLOOD OF THE PLAINTIFF.

  Patient problems: Ambulation or Postural Difficulties; Infiltration into Tissue; Pain

  MAUDE report 17060970 ↗
• InjuryMay 17, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2011, DUE TO A DEGENERATIVE JOINT DISEASE, THE PATIENT EXPERIENCED PAIN, METALLOSIS AND PSEUDOTUMOR FORMATION. A THR REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO ADDRESS THIS COMPLICATION. DURING THIS PROCEDURE, THE RESURFACING FEMORAL HEAD AND CUP WERE EXPLANTED AND REPLACED WITH COMPETITOR¿S DEVICES. INTRAOPERATIVELY, AFTER ENTERING THE CAPSULE SIGNIFICANT RUSH OF SLIGHTLY CLOUDY YELLOW JOINT FLUID AND ACETABULAR BONE LOSS WAS FOUND. ALSO, AFTER REMOVING THE FEMORAL COMPONENT AND PART OF THE FEMORAL NECK SIGNIFICANT PSEUDOTUMOR FORMATION DOWN INSIDE THE FEMUR AS WELL THAT EXTENDED PAST THE LESSER TROCHANTER SLIGHTLY AND CREATED A CAVITARY LESION IN THE PROXIMAL FEMUR WAS FOUND. THE PROCEDURE WENT UNEVENTFUL, AND THE PATIENT WAS TRANSFER TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 16947760 ↗
• InjuryApr 25, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON LITERATURE REVIEW "HOW MUCH DOES A MEDICAL AND HEALTHCARE PRODUCTS REGULATORY AGENCY MEDICAL DEVICE ALERT FOR METAL-ON-METAL HIP ARTHROPLASTY PATIENTS REALLY COST?", ONE (1) PATIENT WAS CONFIRMED WITH ADVERSE REACTION TO METAL DEBRIS (ARMD) AND COBALT/CHROMIUM LEVELS AT 7,85 UG/L AND 9,73 UG/L RESPECTIVELY AFTER UNDERGOING A BHR RESUFACING PROCEDURE. THE EVENT WAS TREATED BY REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: High metal ion levels

  MAUDE report 16811456 ↗
• InjuryApr 25, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON LITERATURE REVIEW "HOW MUCH DOES A MEDICAL AND HEALTHCARE PRODUCTS REGULATORY AGENCY MEDICAL DEVICE ALERT FOR METAL-ON-METAL HIP ARTHROPLASTY PATIENTS REALLY COST?", ONE (1) PATIENT WAS CONFIRMED WITH ADVERSE REACTION TO METAL DEBRIS (ARMD) AND COBALT/CHROMIUM LEVELS AT 26,67 UG/L AND 33,57 UG/L RESPECTIVELY AFTER UNDERGOING A BHR RESUFACING PROCEDURE. THE EVENT WAS TREATED BY REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: High metal ion levels

  MAUDE report 16811424 ↗
• InjuryApr 25, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON LITERATURE REVIEW "HOW MUCH DOES A MEDICAL AND HEALTHCARE PRODUCTS REGULATORY AGENCY MEDICAL DEVICE ALERT FOR METAL-ON-METAL HIP ARTHROPLASTY PATIENTS REALLY COST?", ONE (1) PATIENT WAS CONFIRMED WITH ADVERSE REACTION TO METAL DEBRIS (ARMD) AND COBALT/CHROMIUM LEVELS AT 17,21 UG/L AND 23,3 UG/L RESPECTIVELY AFTER UNDERGOING A BHR RESURFACING PROCEDURE. THE EVENT WAS TREATED BY REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: High metal ion levels

  MAUDE report 16811400 ↗
• InjuryApr 25, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON LITERATURE REVIEW "HOW MUCH DOES A MEDICAL AND HEALTHCARE PRODUCTS REGULATORY AGENCY MEDICAL DEVICE ALERT FOR METAL-ON-METAL HIP ARTHROPLASTY PATIENTS REALLY COST?", ONE (1) PATIENT WAS CONFIRMED WITH LYSIS AROUND THE STEM, ADVERSE REACTION TO METAL DEBRIS (ARMD) AND COBALT/CHROMIUM LEVELS AT 4,99 UG/L AND 17,93 UG/L RESPECTIVELY AFTER UNDERGOING A BHR RESUFACING PROCEDURE. THE EVENT WAS TREATED BY REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: High metal ion levels

  MAUDE report 16811281 ↗
• InjuryApr 25, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON LITERATURE REVIEW "HOW MUCH DOES A MEDICAL AND HEALTHCARE PRODUCTS REGULATORY AGENCY MEDICAL DEVICE ALERT FOR METAL-ON-METAL HIP ARTHROPLASTY PATIENTS REALLY COST?", ONE (1) PATIENT PRESENTED A LOOSE STEM AND COBALT/CHROMIUM LEVELS AT 1,35 UG/L AND 0,29 UG/L RESPECTIVELY AFTER UNDERGOING A BHR RESUFACING PROCEDURE. THE EVENT WAS TREATED BY REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16811234 ↗
• InjuryApr 25, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON LITERATURE REVIEW "HOW MUCH DOES A MEDICAL AND HEALTHCARE PRODUCTS REGULATORY AGENCY MEDICAL DEVICE ALERT FOR METAL-ON-METAL HIP ARTHROPLASTY PATIENTS REALLY COST?", ONE (1) PATIENT WAS CONFIRMED WITH ADVERSE REACTION TO METAL DEBRIS (ARMD) AND COBALT/CHROMIUM LEVELS AT 12,22 UG/L AND 19,59 UG/L RESPECTIVELY AFTER UNDERGOING A BHR RESURFACING PROCEDURE. THE EVENT WAS TREATED BY REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: High metal ion levels; Metal Related Pathology

  MAUDE report 16811153 ↗

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-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-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-0030-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. 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-0031-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. 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-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.