BIRMINGHAM HIP RESURFACING (BHR) 74120156Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 03596010502599), received between Apr 25, 2017 and Jun 14, 2025 — classified as 3 deaths, 139 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (53 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 145 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2007, HE EXPERIENCED ELEVATED CHROMIUM/COBALT LEVELS. HE HAS BEEN IN PAIN SINCE 2020, SUFFERING ISSUES WITH BALANCE, COORDINATION, NEUROPATHY THAT HE BELIEVES IS LINKED TO HIS METAL LEVELS. SEVERAL STUDIES HAVE BEEN MADE TO THE LEFT HIP, BUT THE IMPLANTS APPEAR TO BE WELL FIXED AND THERE IS NO EVIDENCE OF IMPLANT COMPLICATION. THE PATIENT HAS UNDERGONE MULTIPLE TREATMENTS OF CHELATION THERAPY TO REDUCE COBALT AND CHROME IONS IN HIS BLOODSTREAM. IT IS UNKNOWN IF A REVISION SURGERY IS SCHEDULED OR IF IT WILL BE SCHEDULED, AT THE TIME. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Balance Problems; High metal ion levels; Neuropathy

  MAUDE report 22208222 ↗
• InjuryMay 9, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN FOR YEARS, DESCRIBED AS SHARP AND ACHES. IT IS WORSE WITH WEIGHTBEARING ACTIVITIES. PATIENT ALSO MENTIONED THAT HE HAS EXPERIENCED SEVERAL DISLOCATIONS PER YEAR. HE ALSO EXPERIENCED SWELLING, A TRENDELENBURG LIMP, AND WAS CONCERNED ABOUT X-RAYS CHANGES. METAL IONS LEVELS WERE SIGNIFICANTLY ELEVATED ALSO AND MRI CONFIRMED ABDUCTOR DESTRUCTION AND A LARGE PSEUDOTUMOR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THERE WAS SIGNIFICANT METAL REACTION FLUID THAT WAS IRRIGATED FROM THE HIP JOINT. THERE WAS NO DISCERNIBLE POSTERIOR CAPSULE. A SIGNIFICANT AMOUNT OF NECROTIC MUSCLE WAS NOTICED, INCLUDING THE ABDUCTORS, VASTUS LATERALIS AND RECTUS. THE GREATER TROCHANTER WAS COMPLETELY DEVOID OF ANY ABDUCTOR ATTACHMENT. AN EXTENSIVE DEBRIDEMENT INVOLVING THE SUPERFICIAL FASCIAL AND DEEP LAYERS WAS DONE. A SIGNIFICANT AMOUNT OF ABDUCTOR MUSCULATURE WAS EXCISED, AS WELL AS POSTERIOR CAPSULAR STRUCTURE. THE HIP WAS DISLOCATED, THE PROXIMAL FEMUR WAS EXPOSED AND THE MODULAR HEAD WAS REMOVED. THEN, THE ACETABULAR COMPONENT WAS EXPOSED, WAS NOTICED TO BE RETROVER

  Patient problems: Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 21993742 ↗
• InjuryMay 2, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2009, AN MRI IN 2017 SHOWED EVIDENCE OF SEVERE METALLOSIS, AND BLOOD TESTS ALSO SHOWED ELEVATED IONS. EXAMS ALSO SHOWED THE PATIENT WAS WALKING WITH A TRENDELENBURG GAIT. HE WAS ADDITIONALLY UNABLE TO SINGLE STANCE STAND WITHOUT DIFFICULTY ON THE LEFT LEG. THE SURGEON RECOMMENDED IN 2019 TO PERFORM A REVISION SURGERY DUE TO THE BHR ISSUES HE HAD BEEN EXPERIENCING, BUT PATIENT DEFERRED AT THAT TIME. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. WHEN SURGEON OPENED THE FASCIA, A VOLCANIC-LIKE FLUID ERUPTION OCCURRED WITH METALLOSIS FLUID, WHICH WAS EVACUATED AND DEBRIDED. SEVERE METALLOSIS AND PSEUDOTUMOR REACTION WERE NOTICED REPLACING A SIGNIFICANT PORTION OF HIS PROXIMAL VASTUS LATERALIS, GLUTEUS MEDIUS AND ENTIRE ANTERIOR CAPSULE INTO THE ILIOPSOAS SHEATH. HE HAD NO MUSCULAR ATTACHMENT TO THE PROXIMAL FEMUR EXCEPT FOR THE SHORT EXTERNAL ROTATORS POSTERIORLY. AGGRESSIVE DEBRIDEMENT OF HIS PSEUDOTUMOR BENIGN NEOPLASM WAS DONE. PICKUPS AND A KNIFE WAS USED TO DISCARD THE NECROTIC APPEARING PSEUDOTUMOR FROM THE LATERAL FEMUR, ANTERIOR FEMUR AND THE AREA OF THE ANTERIOR CAPSULE. FOR TH

  Patient problems: Deformity/ Disfigurement; Metal Related Pathology; Pain

  MAUDE report 21950781 ↗
• InjuryNov 19, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A THA-BHR ON (B)(6) 2009 DUE TO END-STAGE OSTEOARTHRITIS OF THE RIGHT HIP. PATIENT SUFFERED FROM PAINFUL RIGHT TOTAL HIP ARTHROPLASTY WITH METALLOSIS AS WELL AS ELEVATED CHROMIUM AND COBALT SERUM LEVELS. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2023, DURING WHICH THE ACETLR CUP HAP 56MM W/ IMPTR AND RESURFACING FEMORAL HEAD 50MM WERE EXPLANTED. DURING PROCEDURE, UPON OPENING OF THE HIP CAPSULE, THERE WAS BROWN MATERIAL PRESENTED. THE TRUNNION WAS INSPECTED AND IT HAD BLACK MELANOSIS, HOWEVER, IT WAS EASY REMOVED. PATIENT TOLERATED THE PROCEDURE WELL AND WENT TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 20722565 ↗
• MalfunctionSep 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A BHR PROCEDURE, THO CABLE FROM A ACETLR CUP HAP 56MM W/ IMPTR BROKE PREMATURELY, DURING THE IMPLANTATION OF THE CUP. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF A DELAY OCCURRED DUE TO THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126745 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT BHR SURGERY ON (B)(6) 2007, THE PATIENT HAD A FALL ON (B)(6) 2007 WITH SUBSEQUENT HIP PAIN, LEG WEAKNESS AND A TINGLING FEELING LEFT LOWER LEG/FOOT/ANKLE. ON (B)(6) 2017, AN MRI SHOWED A STRESS FRACTURE AND ON (B)(6) 2018 ANOTHER MRI SHOWED A LARGE JOINT EFFUSION. ON (B)(6) 2018 SHE HAD A SUDDEN SHARP PAIN IN HER LEFT HIP, WHICH CAUSED HER TO DOUBLE OVER. SHE FELL TO THE GROUND DIRECTLY ON HER KNEE. SHE IMMEDIATELY HAD PAIN IN HER KNEE AND HAD DIFFICULTY WITH WALKING. TREATMENTS SO FAR HAVE INCLUDED THE ASSISTIVE USE OF A BRACE AND CRUTCHES. PAIN MANAGEMENT IS COORDINATING HER PAIN REGIMEN.

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

  MAUDE report 19651539 ↗
• InjuryMay 23, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PATIENT UNDERWENT A RIGHT PRIMARY BHR ON (B)(6) 2015. THE PATIENT LATER DEVELOPED HIGH LEVELS OF COBALT AND CHROMIUM, AND A MRI SHOWED LARGE FLUID COLLECTION AND EARLY DESTRUCTION OF SOME MUSCLES. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH BOTH BHR COMPONENTS WERE EXPLANTED, AND THE HIP WAS CONVERTED INTO A THA WITH COMPETITOR DEVICES. THE PATIENT WAS SENT TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Arrhythmia; Blurred Vision; Metal Related Pathology; Partial Hearing Loss; Tinnitus

  MAUDE report 19382573 ↗
• InjuryMay 20, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A BILATERAL PLAINTIFF UNDERWENT A LEFT BHT-THA ON (B)(6) 2010, THEY WERE LATER DIAGNOSED WITH AVAL, A MECHANICAL COMPLICATION, ABNORMALLY ELEVATED COBALT AND CHROMIUM LEVELS, AND AN MRI DEMONSTRATED PSEUDOTUMOR, IN BOTH HIPS, WORSE IN LEFT. THEREFORE, A REVISION SURGERY OF THE LEFT HIP WAS PERFORMED ON (B)(6) 2023, TO EXPLANT THE BHR CUP AND THE BHR MODULAR, AND REPLACE THEM WITH A ZIMMER DUAL MOBILITY CROSSLINKED POLY AND BIOLOX FEMORAL HEAD. THEIR POST OP FOLLOW UPS DEMONSTRATED A GOOD RECOVERY, WALKING WITHOUT ASSISTANCE AND MINIMAL PAIN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19350329 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAINTIFF PRESENTED A CLAIM DUE TO PAIN AFTER HAVING A RIGHT HIP BHR PRIMARY SURGERY ON (B)(6) 2015. THE PATIENT WAS TREATED WITH CORTISONE INJECTIONS. CURRENTLY, THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Arthralgia

  MAUDE report 19325830 ↗
• InjuryMay 9, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PLAINTIFF THAT UNDERWENT A RIGHT BHR PROCEDURE ON (B)(6) 2012, WAS FOUND TO HAVE METAL DEBRIS AND PSEUDOTUMORS IN THEIR RIGHT KNEE, VIA AN MRI ON (B)(6) 2016. THEREFORE, A REVISION WAS PERFORMED ON (B)(6) 2016 TO TREAT THIS ADVERSE EVENT, DURING WHICH THE BHR ACETABULAR AND FEMORAL COMPONENTS WERE EXCHANGED FOR A ZIMMER CERAMIC-CERAMIC SYSTEM. PATIENT'S CURRENT HEALTH STATUS IN UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 19279187 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A CHRONIC INFECTION AND REQUIRED A 2-STAGE REVISION SURGERY. DURING THE FIRST STEP OF THE REVISION SURGERY, ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH A NAILING SYSTEM AND ANTIBIOTIC CEMENT. THE PATIENT WOKE UP FROM THE PROCEDURE AND WAS TRANSFERRED TO PACU IN STABLE CONDITION. NO INFORMATION ABOUT THE SECOND STAGE OF THE REVISION SURGERY HAS BEEN PROVIDED YET. THE 2-STAGE REVISION SURGERY MENTIONED CORRESPONDS TO THE THIRD REVISION SURGERY THAT THIS PATIENT HAS EVER REQUIRED FOR HIS RIGHT HIP. HE UNDERWENT A PRIMARY METAL ON METAL HIP ARTHROPLASTY, LATER REQUIRED A FIRST REVISION SURGERY TO CONVERT THE SYSTEM WITH A DUAL MOBILITY COMPONENT, AND LATER REQUIRED A SECOND REVISION SURGERY DUE TO INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 19271062 ↗
• InjuryMar 20, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A RIGHT PRIMARY BHR ON (B)(6) 2006 AND LATER WAS DIAGNOSED TO HAVE A FAILED BHR. THEREFORE, A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2016, DURING WHICH STAINING AT THE LOWER END OF THE ACETABULUM AND CYSTS IN THE ACETABULUM WERE FOUND; THE RESURFACING FEMORAL HEAD 50MM, AND THE ACETLR CUP HAP 56MM W/ IMPTR WERE EXCHANGED FOR COMPETITOR DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 18941201 ↗
• InjuryMar 20, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A LEFT PRIMARY BHR ON (B)(6) 2007 AND LATER WAS DIAGNOSED TO HAVE A FAILED BHR. THEREFORE, A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2015, DURING WHICH FIBROSED/SCARED CAPSULAR TISSUE WAS FOUND AND THE ACETLR CUP HAP 56MM W/ IMPTR AND RESURFACING FEMORAL HEAD 50MM WERE EXCHANGED FOR COMPETITOR DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Scar Tissue

  MAUDE report 18941124 ↗
• InjuryFeb 19, 2024Biocompatibility; Noise, Audible; Biocompatibility; Noise, Audible

  IT WAS REPORTED THAT, A LEFT BHR PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008. A REVISION SURGERY WAS LATER CARRIED OUT ON (B)(6) 2014, BECAUSE THE PLAINTIFF EXPERIENCED CLICKING AND CATCHING OF THE IMPLANTS AND PAIN; AND WAS DIAGNOSED WITH ELEVATED METAL IONS AND A PSEUDOTUMOR. DURING SURGERY COPIOUS METAL STAINED FLUID AND TISSUE NEAR THE PSEUDOCAPSULE WAS FOUND. BOTH BHR COMPONENTS WERE EXCHANGED FOR S+N IMPLANTS, AND THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION. FURTHER COMPLICATIONS HAVE NOT BEEN REPORTED.

  Patient problems: Extraskeletal ossification; Metal Related Pathology

  MAUDE report 18735560 ↗
• InjuryFeb 6, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PRIMARY BHR PROCEDURE WAS PERFORMED ON (B)(6) 2013, AND LATER THE PATIENT EXPERIENCED HIP PAIN. THEREFORE, A REVISION WAS CARRIED OUT ON (B)(6) 2023, DURING WHICH CLOUDY FLUID AROUND THE ACETABULUM, METALLOSIS AND IMPINGEMENT WAS FOUND. BOTH BHR COMPONENTS WERE EXPLANTED, AND A S+N DUAL MOBILITY SHELL, AND A COMPETITOR FEMORAL HEAD AND STEM WERE IMPLANTED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. FURTHER COMPLICATIONS HAVE NOT BEEN REPORTED.

  Patient problems: Joint Impingement; Metal Related Pathology; Pain

  MAUDE report 18654797 ↗
• InjuryJan 26, 2024Material Erosion; Biocompatibility; Material Erosion; Biocompatibility

  IT WAS REPORTED THAT, ON (B)(6) 2017, A PLAINTIFF UNDERWENT A RIGHT BHR PROCEDURE. UPON CONSULT ON (B)(6) 2021, DUE TO LEFT HIP PAIN, IT WAS FOUND THAT THE RIGHT HIP IMPLANT HAD EXPERIENCED SIGNIFICANT WEAR AND TEAR, AND HAD INCREASED RISK OF FRACTURE. THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THE PATIENT WAS REPORTED TO HAVE METALLOSIS, INCREASED NECROSIS OF RIGHT HIP AND SURROUNDINGS, AND IMPAIRED KIDNEY FUNCTION. NO OTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 18591741 ↗
• MalfunctionNov 20, 2023Break; Break

  IT WAS REPORTED THAT, DURING A BHR SURGERY, THE SURGEON TRIED TO IMPLANT A 56MM CUP., BUT WHEN ATTEMPTING IT, THE WIRES THAT HOLD THE ACETLR CUP HAP 56MM W/ IMPTR ON BROKE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172412 ↗
• InjuryOct 16, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT PRIMARY BHMH-THA SURGERY, PERFORMED ON (B)(6) 2009, TO TREAT HIP AVASCULAR NECROSIS, THE PATIENT UNDERWENT A REVISION SURGERY ON THE (B)(6) 2022 WHERE METALLOSIS AND TRUNNIONOSIS WAS NOTED. THE BHMH ACETABULAR AND FEMORAL HEAD COMPONENTS WERE REPLACED BY AN OXONIUM FEMORAL HEAD AND DUAL MOBILITY CUP. THE PATIENT WAS TAKEN TO RECOVERY IN A SATISFACTORY AND STABLE CONDITION. NO OTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 17939652 ↗
• InjuryOct 13, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT PRIMARY BHR-THA SURGERY, PERFORMED ON (B)(6) 2009, THE PLAINTIFF WAS DIAGNOSED WITH ELEVATED COBALT CHROMIUM LEVELS, FOR WHICH A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2023. DURING THE REVISION METALLOSIS WAS FOUND AND THE SOCKET WAS NOTICED TO BE LOOSE. THE ACETABULAR CUP, MODULAR SLEEVE, AND HEMI HEAD WERE REPLACED FOR COMPETITOR DEVICES.

  Patient problems: Metal Related Pathology

  MAUDE report 17936270 ↗
• InjurySep 5, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR PERFORMED ON (B)(6) 2009, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. DURING THE REVISION SURGERY THE POSTERIOR SOFT TISSUES WERE INSPECTED AND IT WAS FOUND A RATHER LARGE CAVITY, REPRESENTING EITHER A HEMOSIDERIN SUSTAINED PREVIOUS SEROMA, OR AN ADVERSE LOCAL TISSUE REACTION TO METAL. THERE WAS NOT A TYPICAL PSEUDOTUMOR. SYNOVITIS WAS PRESENT, SUGGESTING AN ADVERSE REACTION TO TRACE METAL PARTICLES. THE IMPLANTS WERE REMOVED AND REPLACED, CONVERTING IT IN A THR. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology; Synovitis

  MAUDE report 17686602 ↗
• InjurySep 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY (THA) SURGERY ON THE RIGHT HIP ON (B)(6) 2009. THE X-RAYS POST-OPERATIVE SHOWED THAT THE IMPLANTED ACETABULAR CUP HAD SLIPPED. THIS COMPLICATION WAS SOLVED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2009. DURING THE PROCEDURE, IT WAS NOTICED THAT THE INFERIOR EDGE OF THE ACETABULUM HAD INDEED BECOME DISPLACED. THE DEVICES WERE EXPLANTED AND REPLACED EXCEPT FOR THE FEMORAL STEM. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Joint Dislocation

  MAUDE report 17684023 ↗
• InjurySep 5, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A LEFT BIRMINGHAM HIP RESURFACING ON (B)(6)2006. THE PATIENT HAS UNDERGONE A BLOOD TEST, WHICH SHOWED ELEVATED COBALT AT 8.4MCG/L AND HE HAS ALSO HAD MANY SYSTEMIC SYMPTOMS OVER THE PAST YEAR FOR WHICH HE HAS UNDERGONE EXTENSIVE WORK-UP RECENTLY AND WAS CONCERNED THIS COULD BE DUE TO ELEVATED METAL LEVELS. THE PATIENT TO DATE HAS NOT UNDERGONE A REVISION SURGERY ON THE LEFT HIP. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: High metal ion levels

  MAUDE report 17683913 ↗
• InjuryAug 4, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THE PATIENT HASN¿T UNDERGONE A MEDICALLY-INDICATED REVISION OF THE BHR RIGHT HIP IMPLANTS YET. ALTHOUGH THE RIGHT HIP HAS NOT BEEN REVISED, THE RIGHT HIP CONTRIBUTION TO THE ELEVATED ION LEVELS ON BLOOD CANNOT BE DISCARDED.

  Patient problems: High metal ion levels

  MAUDE report 17466117 ↗
• InjuryMay 15, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A BHR SYSTEM HAD BEEN IMPLANTED ON PLAINTIFF´S LEFT HIP ON (B)(6) 2010 DUE TO OSTEOARTHRITIS, THE PLAINTIFF EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High metal ion levels; Insufficient Information; Scar Tissue

  MAUDE report 16935795 ↗
• InjuryMay 15, 2023Biocompatibility; Insufficient Device Problem Information; Biocompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING SYSTEM HAD BEEN IMPLANTED ON PATIENT RIGHT HIP ON (B)(6) 2015 DUE TO ADVANCED DEGENERATIVE ARTHRITIS, THE PLAINTIFF EXPERIENCED REVISION SURGERY ON (B)(6) 2022 DUE TO ELEVATED METAL ION LEVELS AND PAIN. DURING THE REVISION, EVIDENCE OF METALLOSIS IN THE CAPSULE AND SMALL PSEUTOTUMOR MEDIALLY WERE FOUND. FEMORAL HEAD AND CUP WERE EXPLANTED AND EXCHANGED FOR COMPETITOR DEVICES. PATIENT AWOKEN FROM ANESTHESIA AND TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 16935783 ↗

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-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-0027-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. 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-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. 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-0028-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. 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-0033-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. 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-0030-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component.

…and 14 more.