BIRMINGHAM HIP RESURFACING (BHR) 74122158Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 03596010552310), received between Mar 30, 2016 and May 18, 2026 — classified as 64 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (26 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Fracture

  IT WAS REPORTED THAT, DURING A BHR SURGERY, WHEN THE SURGEON WAS IMPACTING THE ACETABULAR CUP INTO THE PATIENT, A WIRE OF ONE (1) ACETABULAR CUP HAP SIZE 52/58 WAS DETACHED FROM ITS CONNECTION POINT. NO FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211745 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED A PERIPROSTHETIC INFECTION. THIS ADVERSE EVENT WAS ADDRESS BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE ACETABULAR CUP HAP SIZE 52/58 AND THE FEMORAL HEAD 52MM WERE REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22465193 ↗
• InjuryMay 15, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, THE PLAINTIFF UNDERWENT A RIGHT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2012 AND A LEFT BHR PERFORMED ON AN UNSPECIFIED DATE, AND AFTER THIS THE PATIENT HAS BEEN EXPERIENCING PAIN AND HIGH LEVELS OF CHROMIUM AND COBALT. HE HAS BEEN DIAGNOSED WITH COBALT POISONING DUE TO HIS METAL-ON-METAL HIP REPLACEMENT, WHICH HAS ALSO AFFECTED HIS OTHER HIP. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO CONCERN OF INFECTION (BUT THIS HAS BEEN RULED OUT). THE CUP AND FEMORAL HEAD WERE EXPLANTED AN REPLACED FOR COMPETITOR IMPLANTS. AFTER THIS, THE PATIENT SUFFERED FROM 2 DISLOCATIONS AND AN ADDITIONAL REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH THE COMPETITOR DEVICES WERE EXPLANTED AND REPLACED FOR A DUAL MOBILITY CONSTRUCT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 22023911 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE MOUNTING ONE (1) ACETABULAR CUP HAP SIZE 52/58, THE WIRE SNAPPED. THE PROCEDURE WAS RESUMED, AFTER A DELAY OF LESS THAN 30 MINUTES, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860919 ↗
• InjuryJun 4, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A LEFT HIP RESURFACING (BHR) ON (B)(6) 2009 DUE TO DEGENERATIVE JOINT DISEASE, THE PATIENT DEVELOPED PERSISTENT PAIN. A SUBSEQUENT DIAGNOSIS REVEALED ELEVATED CHROMIUM AND COBALT LEVELS, OSTEOLYSIS AND CYST FORMATION AROUND THE ANTERIOR ACETABULAR COLUMN, FOR WHICH A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. DURING THIS PROCEDURE, BOTH RESURFACING COMPONENTS WERE REMOVED AND CONVERSION TO A THA SYSTEM (SMITH+NEPHEW COMBINED WITH DEPUY SYNTHES) WAS PERFORMED. PATIENT WAS REPORTED TO HAVE A GOOD RECOVERY ON A POST-OPERATIVE VISIT.

  Patient problems: Metal Related Pathology

  MAUDE report 19463255 ↗
• InjuryMay 20, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A BILATERAL PLAINTIFF UNDERWENT A RIGHT BHR-THA ON (B)(6) 2009. THE PATIENT WAS LATER DIAGNOSED WITH AVAL, PAIN, ABNORMALLY ELEVATED CHROME COBALT AND IRON LEVELS, AND AN MRI DEMONSTRATED PSEUDOTUMOR, IN BOTH HIPS. THEREFORE, A REVISION SURGERY OF THE RIGHT HIP WAS PERFORMED ON (B)(6) 2023. THE BHR ACETABULAR CUP, AND THE BHR MODULAR HEAD WERE EXPLANTED AND REPLACED BY A ZIMMER DUAL MOBILITY CROSSLINKED POLY AND BIOLOX FEMORAL HEAD. THE PATIENT WAS DISCHARGED IN STABLE CONDITION, AND THREE WEEKS AFTER THE REVISION THEY WERE WALKING WITH NO ASSISTIVE DEVICES.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19350346 ↗
• InjuryNov 15, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2012, FOR THE PAST TWO YEARS THE PATIENT STARTED EXPERIENCING NUMBNESS AND PAIN IN BOTH LEGS AND FEET, AND HAVE MOBILITY PROBLEMS IN THE RIGHT HIP. ON (B)(6) 2023, UNDERWENT BLOOD TEST EXAMS AND IT WAS DETECTED WITH HIGH CHROMIUM AND COBALT LEVELS IN HIS BLOOD, ALSO MRI RESULTS SHOWED ISSUES. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT, IN WHICH A BHR RESURFACING FEMORAL HEAD 52MM AND A 58MM BHR ACETABULAR CUP WERE EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS GOOD, BUT STILL RECOVERING.

  Patient problems: High metal ion levels; Loss of Range of Motion; Pain

  MAUDE report 18139099 ↗
• InjuryOct 19, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR TKA SURGERY PERFORMED ON (B)(6) 2012, THE PLAINTIFF PRESENTED ELEVATED LEVELS OF METAL IONS. ON (B)(6) 2023 HE UNDERWENT UNDER A MEDICALLY INDICATED REVISION SURGERY OF THE LEFT HIP AND CONVERTED INTO DUAL MOBILITY HIP. NO SIGNS OF INFECTION, IMPLANT LOOSENING OR OSTEOLYSIS WERE NOTICED IN THE PATIENT DURING THE SURGERY. A CYST WAS NOTED IN THE ANTERIOR SUPERIOR ACETABULUM, WHICH DID SHOW SOME EARLY METALLOSIS. THE SURGEON DECIDED TO EXPLANT THE PREVIOUS BHR IMPLANTS AND REPLACE THE WITH DUAL MOBILITY COMPETITOR IMPLANTS. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 17966032 ↗
• InjurySep 5, 2023Malposition of Device; Biocompatibility; Noise, Audible; Malposition of Device; Biocompatibility; Noise, Audible

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY (THA) REVISION SURGERY ON THE RIGHT HIP ON (B)(6) 2009. WITH THE PASSAGE OF TIME, THE PATIENT HAS BEEN HAVING TROUBLES WITH THE IMPLANTS SQUEAKING SINCE ABOUT 8 MONTHS OR SO POSTOPERATIVE AND IT WAS GETTING WORSE. THE PATIENT UNDERWENT BLOOD TESTS WHERE COBALT AND CHROMIUM LEVELS WERE FOUND TO BE ELEVATED. THIS COMPLICATION WAS TREATED BY CONDUCTING A SECOND REVISION SURGERY ON (B)(6) 2015. DURING THE PROCEDURE IT WAS NOTICED THAT THE CUP LOOKED A LITTLE BIT ON THE ANTEVERTED SIDE AND THERE WAS NO BONE DESTRUCTION AND NO SOFT TISSUE DAMAGE. THE DEVICES WERE EXPLANTED AND REPLACED EXCEPT FOR THE FEMORAL STEM. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Discomfort; High metal ion levels

  MAUDE report 17684058 ↗
• MalfunctionAug 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A BHR SURGERY, THE INTRODUCER WIRE OF AN ACETABULAR CUP HAP SIZE 52/58 SNAPPED DURING IMPACTION. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435513 ↗
• InjuryMay 18, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A BILATERAL PATIENT HAD A TOTAL HIPS ARTHROPLASTY IN THE RIGHT HIP PERFORMED ON (B)(6) 2009 DUE TO A SEVERE GENERATIVE JOINT DISEASE IN WHICH A BHR MODULAR SYSTEM WAS IMPLANTED. THE PATIENT HAS DEVELOPED ELEVATED AND INCREASING COBALT AND CHROMIUM METAL ION LEVELS ON SURVEILLANCE TESTING AND AUDIBLE SQUEAKING INTERMITTENTLY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMEDIATE THESE ADVERSE EVENTS. DURING SURGERY, THERE WAS NO VISIBLE TISSUE DAMAGE, METALLOSIS, OR COMPONENT DAMAGE, AND ALL COMPONENTS APPEARED TO BE SOLIDLY SEATED AND WELL FIXED. AFTER THE PROCEDURE, THE PATIENT APPEARED TO TOLERATE THE PROCEDURE WELL AND WITHOUT ANY APPARENT INTRAOPERATIVE COMPLICATIONS

  Patient problems: Discomfort; High metal ion levels; Infiltration into Tissue

  MAUDE report 16957839 ↗
• InjuryMay 16, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP BHR HIP RESURFACING SURGERY ON(B)(6) 2014, THE PATIENT EXPERIENCED MALPOSITIONING OF THE ACETABULAR COMPONENT. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2014. DURING THIS PROCEDURE, IT WAS OBSERVED THAT THE PATIENT PRESENTED OLD HEMATOMA BLOOD, WHICH WAS EVACUATED WITHOUT THE NEED OF A DRAIN. THE ORIGINAL 58 MM BHR CUP WAS REPLACED WITH A 60 MM BHR CUP AND THE FEMORAL HEAD WAS RETAINED.

  Patient problems: Deformity/ Disfigurement; Hematoma

  MAUDE report 16943005 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL IT WAS REPORTED THAT, AFTER A RIGHT BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2010 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED AN INFECTION. A TWO-STAGE REVISION SURGERY WAS PERFORMED TO ADDRESS THIS COMPLICATION. FIRST STAGE PERFORMED ON (B)(6) 2022. DURING THIS PROCEDURE, THE RESURFACING HEAD AND CUP WERE EXPLANTED. INTRAOPERATIVELY, A GROSS PURULENCE WAS IDENTIFIED UPON OPENING THE CAPSULE. THE WOUND WAS THOROUGHLY DEBRIDED, AND AN ANTIBIOTIC SPACER WAS PLACED. THE PROCEDURE WENT UNEVENTFUL, AND THE PATIENT WAS TRANSFER TO RECOVERY ROOM IN STABLE CONDITION. SECOND STAGE REVISION SURGERY DATE IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 16862760 ↗
• InjuryApr 26, 2023Loss of Osseointegration; Loss of Osseointegration

  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 ACETABULAR CUP LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY 48 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: Inadequate Osseointegration

  MAUDE report 16820377 ↗
• InjuryMar 14, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PRIMARY LEFT BHR THA SURGERY PERFORMED ON (B)(6) 2011, THE PLAINTIFF EXPERIENCED RINGING IN HIS EARS, TREMOR, SEVERE PAIN, AND EVIDENCE OF OSTEOLYSIS IN THE ACETABULUM, SO HE UNDERWENT A LEFT HIP REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION, A HUGE AMOUNT OF METALLOSIS WAS FOUND. THE ACETABULAR CUP HAP SIZE 52/58, HEMI HEAD 52MM AND THE MODULAR SLEEVE -4MM 12/14 WERE EXPLANTED AND REPLACED WITH COMPONENTS FROM A COMPETITOR MANUFACTURER (STRYKER). THE SYN POR FEM COMP SZ 15 REMAINED IMPLANTED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis; Pain; Shaking/Tremors

  MAUDE report 16542394 ↗
• InjuryFeb 9, 2023Defective Device; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAINTIFF SUFFERED FROM A LEFT HIP DISLOCATION ON (B)(6) 2022 AND UNDERWENT A POSTERIOR CAPSULE MESH RECONSTRUCTION ON (B)(6) 2022 TO REPAIR THE EXTENSIVE DAMAGE TO HIS LEFT HIP CAUSED BY THE DEFECTIVE METAL-ON-METAL IMPLANT. THIS PATIENT HAD ALREADY SUFFERED A LEFT HIP REVISION SURGERY ON (B)(6) 2022 DUE TO UNKNOWN COMPLICATIONS (COVERED UNDER (B)(4))¿.

  Patient problems: Joint Dislocation; Unspecified Musculoskeletal problem

  MAUDE report 16342939 ↗
• InjuryMay 30, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER RIGHT BHR SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INCREASING METAL LEVELS, PAIN, THICKENING, INFLAMMATION AND A PSEUDOTUMOR. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inflammation; Metal Related Pathology; Pain; Solid Tumor

  MAUDE report 14542803 ↗
• InjuryMay 27, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN, METALLOSIS, TRUNNIONOSIS AND LOWER EXTREMITY SWELLING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR HEMI HEAD WAS REMOVED FROM THE TRUNNION AND REPLACED WITH A 28+ OXINIUM HEAD AND A DUAL MOBILITY INSERT THAT MATCHED THE ORIGINAL 52MM BHR ACETABULAR CUP. DVT PROPHYLAXIS MEDICATION AND BROAD-SPECTRUM ANTIBIOTICS WERE ADMINISTERED AFTER CONCLUDING THIS PROCEDURE.

  Patient problems: Arthralgia; Metal Related Pathology; Swelling/ Edema

  MAUDE report 14527738 ↗
• InjuryApr 8, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT HIP BHR SURGERY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED PAIN, ELEVATED COBALT AND CHROMIUM LEVELS, ADVERSE LOCAL TISSUE REACTION AND PSEUDOTUMOR. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A THA SYSTEM. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN

  Patient problems: Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 14054913 ↗
• InjuryApr 5, 2022Biocompatibility; Biocompatibility

  US LEGAL MDL. IT WAS REPORTED THAT, AFTER RIGHT BHR SURGERY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED ELEVATED COBALT AND CHROMIUM LEVELS, AS WELL AS A PSEUDOTUMOR. 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; Solid Tumor

  MAUDE report 14007655 ↗
• InjuryApr 1, 2022Biocompatibility; Biocompatibility

  US LEGAL MDL: IT WAS REPORTED THAT, AFTER RIGHT HIP BHR SURGERY WAS PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED PERSISTENT PAIN, ELEVATED COBALT AND CHROMIUM LEVELS, AND TISSUE CORROSION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, AN ABUNDANT AMOUNT OF TISSUE REACTION TO THE METAL DEBRIS WITH DISCOLORATION WAS FOUND, AS WELL AS FEMORAL BONE LOSS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Implant Pain; Metal Related Pathology; Osteopenia/ Osteoporosis; Pain; Tissue Breakdown

  MAUDE report 13975491 ↗
• InjuryMar 24, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A HIP REPLACEMENT SURGERY PERFORMED ON (B)(6) 2013, A REVISION SURGERY WAS PERFORMED DUE TO MECHANICAL COMPLICATION AND METALLOSIS ON (B)(6) 2022. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 13896526 ↗
• MalfunctionJan 7, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT, UPON INSERTING AN ACETABULAR CUP HAP SIZE 52/58 IN A BHR CURVED CUP INTRODUCER, THE SURGEON NOTICED THAT THE FIXATION FINS WERE NOT CORRECTLY ALIGNED. THE PLASTIC CAP OF THE ACETABULAR CUP WAS DISORIENTATED, COMPROMISING A PROPER POSITIONING OF THE IMPLANT ON THE PATIENT'S ACETABULUM. GIVEN THE FACT THAT THERE WERE NO BACK UP IMPLANTS, THE SURGEON REQUESTED A BHR STREAMLINE INTRODUCER TO COMPLETE THE PROCEDURE BY POSITIONING THE SAME IMPLANT. A DELAY GREATER THAN 30 MINUTES WAS REPORTED TO OCCUR DURING THE BHR SURGERY. NO PATIENT HARM WAS REPORTED TO OCCUR DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195592 ↗
• InjuryDec 20, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER THE LEFT BHR ON (B)(6) 2020, THE PLAINTIFF HAS SUFFERED FROM PERSISTENT AND EXTENSIVE PAIN IN THE LEFT HIP WITH WEAKNESS IN THE LEFT LEG, PLAINTIFF HAD FLUID ACCUMULATION IN THE SOFT TISSUE OF THE LEFT HIP AND WAS DIAGNOSED WITH LEFT HIP FAILURE WITH ALVAL COMPATIBLE WITH METALLOSIS. PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2021, WHERE INTRAOPERATIVE FINDINGS DEMONSTRATED FAILED TOTAL HIP RESURFACING WITH ALVAL. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 13046848 ↗
• InjuryNov 9, 2021Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT, AFTER A RIGHT BHR HAD BEEN PERFORMED ON (B)(6) 2011, PLAINTIFF EXPERIENCED HIP PAIN AND LOSS OF FUNCTION ALSO IT HAS PRESENTED ELEVATED COBALT IONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THE ADVERSE EVENTS. PATIENT OUTCOME IS UNKNOWN.

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

  MAUDE report 12778778 ↗

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-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. 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-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-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. 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.
• Z-0026-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. 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-0025-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component.

…and 14 more.