BIRMINGHAM HIP RESURFACING (BHR) 74121150Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 03596010502797), received between May 11, 2018 and Oct 31, 2025 — classified as 1 death, 85 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 86 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR SURGERY, THAT HAD BEEN PERFORMED IN 2017, THE PATIENT WAS UNHAPPY AND HAD AN ADDUCTOR REPAIR AT SOME POINT. X-RAYS SHOWED A REDUCTION IN LEG LENGTH AND OFFSET. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025. INTRAOPERATIVELY, A NOTICEABLE NOTCHING OF THE FEMORAL NECK WAS OBSERVED. THE HEAD WAS CUT AND A HIP STEM WITH BDMH WERE IMPLANTED. THE PATIENT IS CURRENTLY WELL.

  Patient problems: Bone Notching; Unequal Limb Length

  MAUDE report 23438558 ↗
• InjuryJun 13, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A RIGHT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2008, 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. THE PATIENT HAS ALSO UNDERGONE MULTIPLE TREATMENTS OF CHELATION THERAPY TO REDUCE COBALT AND CHROME IONS IN HIS BLOODSTREAM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE SURGEON NOTICED THAT THERE WAS NO EVIDENCE OF SEVERE INTRA-ARTICULAR METALLOSIS AND NO SIGNS OF INFECTION. THERE WAS A MODULAR TAPER WITHIN THE JUNCTION OF THE NECK AND THE LARGE METALLIC HEAD, NOTING THAT 2 PARTS OF THE HIP REPLACEMENT WERE REMOVED. THERE IS ALSO NOTED TO BE A SUBSTANTIAL AMOUNT OF CORROSION WITHIN THE DEEP ASPECT OF THE ARTICULATION ON THE HEAD SIDE. THIS WAS SOMEWHAT SURPRISING AS THERE WAS NOT SIGNIFICANT CORROSION ON THE INNER PORTION OF THE TAPER NOR ON THE TAPER OF THE FEMORAL STEM. IT WAS SURGEON¿S IMPRESSION THAT THE CORROSION WAS LIKELY DUE TO THE DIFFERENT METALS OF THE TAPER SLEEVE AND THE LARGE FEMORAL HEAD TAPER ENGAGEMENT. THE CUP WAS CHECKED AND FOUND TO BE WELL-FIXED. AS SUCH, THE TRUNNION

  Patient problems: Metal Related Pathology

  MAUDE report 22203006 ↗
• InjuryJun 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2007, HE EXPERIENCED A FEMORAL NECK FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2007, IN WHICH THE BHR WAS CONVERTED INTO A THA. THE FRACTURED FEMORAL HEAD AND NECK WERE EXPLANTED AND REPLACED FOR A SYNERGY STEM AND A NEW 50MM METAL FEMORAL HEAD. FURTHER INSPECTION OF THE FEMORAL HEAD REVEALED NO EVIDENCE OF NOTCHING ABOUT THE FEMORAL NECK. THE ACETABULAR COMPONENT WAS IN GOOD POSITION, SO IT WAS RETAINED. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Hip Fracture

  MAUDE report 22199823 ↗
• InjuryDec 19, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A PLAINTIFF RECEIVED A RIGHT BHR SYSTEM ON (B)(6) 2020. THE BHR FAILED AND PATIENT EXPERIENCED PAIN AND TESTED FOR ELEVATED COBALT CHROMIUM IONS, SINCE (B)(6) 2023, THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. DURING SURGERY THE ACETABULAR CUP WAS FOUND TO BE WELL SEATED AND WAS KEPT IN PLACE. THE HIP WAS CONVERTED INTO A THA USING S+N COMPONENTS. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: High metal ion levels; Scar Tissue

  MAUDE report 20977211 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR SURGERY PERFORMED ON AN UNSPECIFIED DATE, A REVISION WAS PERFORMED ON (B)(6) 2024 IN ORDER TO REPLACE THE 50MM BHR FEMORAL HEAD ROW TO A 240 REDAPT AND BHR DUAL MOBILITY HEAD WITH 28 +4 OX HEAD. THE REASON OF THE REVISION SURGERY AND THE HEALTH STATUS OF THE PATIENT IS CURRENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20169958 ↗
• InjuryJul 30, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PLAINTIFF UNDERWENT A RIGHT BHR PROCEDURE ON (B)(6) 2011, PATIENT EXPERIENCED LOW GRADE PAIN FOR 6-7 YEARS, PATIENT WAS LATER ALSO DIAGNOSED WITH ELEVATED COBALT LEVELS, AND X-RAYS DEMONSTRATED A LOOSENED FEMORAL COMPONENT. PATIENT REPORTS SHE HAD A BIKING ACCIDENT 2 WEEKS AGO WITH SEVERE PAIN AFTERWARDS. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO TREAT THE FAILED BHR. DURING THE SURGERY, A BLACKENED STAINED JOINT CAPSULE WAS IDENTIFIED AND THE ACETABULAR COMPONENT WAS FOUND TO BE STABLE; THEREFORE, ONLY THE FEMORAL HEAD WAS EXCHANGED FOR COMPETITOR THR DEVICES. FINAL AP AND LATERAL X-RAYS WERE TAKEN; NO FRACTURE OR COMPLICATION WAS IDENTIFIED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Metal Related Pathology; Pain

  MAUDE report 19862713 ↗
• InjuryJul 29, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A LEFT BHR SURGERY PERFORMED ON (B)(6) 2012 DUE TO AN AVASCULAR NECROSIS AND SEVERE PAIN, THE PATIENT EXPERIENCED A LOOSENING OF THE FEMORAL COMPONENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 IN ORDER TO EXPLANT THE FEMORAL COMPONENT AND CONVERT THE BHR INTO A DUAL MOBILITY ACETABULAR ARTHROPLASTY. MICROMOTION ALONG THE FEMORAL NECK COULD BE SEEN WITH THE FEMORAL COMPONENT. THE CUP WAS NOTICED TO BE IN A SATISFACTORY POSITION, SO IT WAS RETAINED. NO SIGNIFICANT STAINING OF THE TISSUES WERE NOTICED. A CYSTIC REGION WAS IDENTIFIED AND CURETTED, THIS HAD A BENIGN APPEARANCE. A DUAL MOBILITY ACETABULAR LINER, A SUMMIT STEM AND A CERAMIC HEAD FROM A COMPETITOR WERE IMPLANTED. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 19851716 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP RESURFACING (BHR) ON (B)(6) 2007 DUE TO DEGENERATIVE ARTHRITIS, THE PATIENT PRESENTED WITH AN HYPERTROPHIC AND HEAVILY SCARRED TROCHANTERIC BURSA. THIS EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2023, DURING WHICH CONVERSION TO THA WAS CONDUCTED. THE RESURFACING HEAD WAS REMOVED AND REPLACED WITH A 28MM OXINIUM FEMORAL HEAD IN COMBINATION WITH A 56MMX50MM DUAL MOBILITY LINER AND A SIZE 4 POLARSTEM FEMORAL COMPONENT. THE 56MM BHR ACETABULAR CUP WAS WELL-FIXED AND THEREFORE RETAINED. THE PATIENT WAS THEN TAKEN TO PACU IN STABLE CONDITION.

  Patient problems: Bursitis

  MAUDE report 19411774 ↗
• InjuryMay 22, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A LEFT BHR SURGERY ON (B)(6) 2007. THE PATIENT PRESENTED EXCESSIVELY HIGH COBALT AND CHROMIUM LEVELS AND PAIN, AND WAS DIAGNOSED WITH METALLOSIS AND SOFT TISSUE TOXICITY WITH PSEUDOTUMOR FORMATION. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. DURING SURGERY THE ACETABULUM WAS FOUND TO BE WELL FIXED, SO IT WAS KEPT IN PLACE AND A S+N BIRMINGHAM DUAL MOBILITY INSERT AND DEPUY DEVICES WERE IMPLANTED. THERE WERE NO SURGERY COMPLICATIONS, PATIENT WAS DELIVERED TO RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Metal Related Pathology; Pain; Peripheral Nervous Injury

  MAUDE report 19378065 ↗
• InjuryNov 6, 2023Migration; Migration

  IT WAS REPORTED THAT, AFTER A BIRMINGHAM HIP RESURFACING SYSTEM THE LEFT SIDE WAS PAINFUL, 8 YEARS AFTER THE SURGERY A BONE SCAN SHOWED POSSIBLE SLIGHT MIGRATION OF THE RESURFACING FEMORAL HEAD 50MM. SO THE LEFT SIDE WAS CONVERTED TO A PRIMARY HIP WITH A BIRMINGHAM DUAL MOBILITY HIP AND THE CUP WAS RETAINED. PATIENT WAS DOING WELL AND THE OTHER HIP (HAD A BIRMINGHAM HIP RESURFACING SYSTEM WAS DOING WELL.

  Patient problems: Implant Pain

  MAUDE report 18078583 ↗
• InjuryOct 13, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A PLAINTIFF UNDERWENT A RIGHT PRIMARY BHR PROCEDURE ON (B)(6) 2006, DUE TO HIP PAIN. LATER, PLAINTIFF WAS DIAGNOSED WITH RAISED METAL IONS AND EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS EVENT. DURING PROCEDURE, THE SYNOVIUM WAS NOTICED TO BE BLACK, AND AN ANTERIOR PSEUDOTUMOR AND OSTEOLYSIS WAS FOUND AROUND THE NECK. THE BHR CUP WAS WELL FIXED AND SHOWED NO DAMAGE; THEREFORE, ONLY THE FEMORAL HEAD WAS EXPLANTED, AND A COMBINATION OF ZIMMER AND S+N DEVICES WERE IMPLANTED. THE PATIENT WAS TAKEN TO THE POST OPERATIVE AREA IN EXCELLENT CONDITION. NO OTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Metal Related Pathology; Osteolysis; Solid Tumor

  MAUDE report 17935149 ↗
• InjuryOct 10, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON 2007, THE PATIENT EXPERIENCED HIGH LEVEL OF COCR IONS. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH A RESURFACING FEMORAL HEAD 50MM WAS EXPLANTED AND EXCHANGED TO A 28MM OXINIUM HEAD, WHILE A POLARSTEM SIZE 3 STANDARD OFFSET UNCEMENTED STEM AND A SIZE 50/28 DUAL MOBILITY INSERT WERE ALSO IMPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: High metal ion levels

  MAUDE report 17907334 ↗
• InjurySep 5, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT BIRMINGHAM HIP RESURFACING VIA POSTERIOR APPROACH ON (B)(6) 2018. THE PATIENT SUFFERED LOCALIZED PAIN TO THE GROIN AND CREAKING TYPE OF NOISE WITH CERTAIN MOVEMENTS. IN ADDITION, THE PATIENT PRESENTED ELEVATED COBALT AND CHROMIUM LEVELS AND A MRI DEMONSTRATED SOME TRACE FLUID AROUND THE BURSA AND ABDUCTOR MUSCLES. THE PATIENT ALSO PRESENTED MANY SYSTEMIC SYMPTOMS OVER THE PAST YEAR. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023. DURING SURGERY, IT WAS NOTICED THERE WAS SOME SUBTLE METAL STAINING IN THE ADJACENT HIP CAPSULE BUT NO DAMAGE TO THE ABDUCTORS, SURROUNDING TISSUES, OR BONES. HIP RESURFACING IMPLANTS WERE REMOVED AND REPLACED. PATIENT ALSO HAS A CONTRALATERAL BIRMINGHAM HIP RESURFACING. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: High metal ion levels; Pain

  MAUDE report 17683945 ↗
• InjurySep 3, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT BHR PRIMARY PROCEDURE ON (B)(6) 2013. AFTER THIS, PATIENT DEVELOPED ASYMPTOMATIC ELEVATED COBALT AND CHROMIUM ION LEVELS. THIS WAS TREATED BY PERFORMING A REVISION SURGERY OF THE BHR IMPLANTS ON (B)(6) 2019. DURING THE REVISION SURGERY, THE BHR CUP WAS DEEMED TO BE SATISFACTORY AND THEREFORE, WAS RETAINED; AND NO ABNORMAL STAINING OF THE TISSUES COULD BE IDENTIFIED. THE BHR FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH AN OXINIUM HEAD AND SYNERGY STEM. THE PATIENT ALSO HAD A LEFT METAL ON METAL COMPETITOR IMPLANT WHICH WAS REVISED THE SAME DAY. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: High metal ion levels

  MAUDE report 17675071 ↗
• InjuryJun 30, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A TOTAL HIP REPLACEMENT IN THE RIGHT HIP USING THE BHR SYSTEM PERFORMED ON (B)(6) 2019 THE PATIENT STARTED TO PRESENT SYMPTOMS OF SQUEAKING, PAIN AND PRESSURE, VISION CHANGE, AND TASTE CHANGE. AT THAT TIME, CHROMIUM SERUM LEVEL WAS ELEVATED TO 8.7 AND COBALT WAS APPROXIMATELY 4. THESE ADVERSE EVENTS WERE RESOLVED VIA REVISION SURGERY PERFORMED ON (B)(6) 2022 WHERE THE FEMORAL HEAD WAS EXPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Arthralgia; Discomfort; High metal ion levels; Taste Disorder; Unspecified Eye / Vision Problem

  MAUDE report 17242184 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT BHR RESURFACING SYSTEM HAD BEEN IMPLANTED ON (B)(6) 2010, THE PLAINTIFF EXPERIENCED PAIN AND FAILURE OF THE METAL ON METAL PROSTHESIS. THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2023. DURING THE REVISION SURGERY, THE ACETABULAR CUP WAS FOUND TO BE IN GOOD POSITION AND WAS LEFT IN PLACE. THE METALLIC FEMORAL HEAD WAS EXPLANTED AND THE SYSTEM WAS TRANSFORMED TO A THA WITH AN XLPE DUAL MOBILITY INSERT + OXINIUM FEMORAL HEAD + POLARSTEM FEMORAL COMPONENT. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; Scar Tissue

  MAUDE report 17113667 ↗
• InjuryMay 14, 2023Mechanical Problem; Biocompatibility; Insufficient Device Problem Information; Mechanical Problem; Biocompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT HIP RESURFACING (BHR) ON (B)(6) 2008 DUE TO OSTEOARTHRITIS, THE PATIENT PRESENTED WORSENING HIP PAIN AND EVIDENCE OF ACETABULAR OSTEOLYSIS IN CONJUNCTION WITH HIP PROTHESIS MECHANICAL COMPLICATION. THESE EVENTS WERE TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE BHR FEMORAL HEAD WAS EXPLANTED, AND THE CUP WAS RETAINED. DURING THIS PROCEDURE, EVIDENCE OF MILD TO MODERATE METAL STAINING OF THE SOFT TISSUES WAS NOTED. SMITH AND NEPHEW¿S DUAL MOBILITY INSERT WAS PLACED, ALONG WITH A COMPETITOR¿S FEMORAL HEAD AND STEM (DJO INC). THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT IN STABLE CONDITION.

  Patient problems: Implant Pain; Insufficient Information; Metal Related Pathology; Osteolysis

  MAUDE report 16928307 ↗
• InjuryApr 27, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A PRIMARY RIGHT HIP BHR SURGERY ON (B)(6)2015. ON AN UNSPECIFIED DATE, THE PLAINTIFF STARTED EXPERIENCING RIGHT HIP PROBLEMS: A LOT OF PAIN, A CLICKING SOUND, HE CAN BARELY WALK, AND IF HE BUMPS INTO SOMETHING THE HIP WILL POP OUT. THE PLAINTIFF HAS HAD PHYSICAL THERAPY AND MULTIPLE TESTS PERFORMED BUT HAS NOT FOUND ANY RELIEF. NO MORE INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Implant Pain; Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 16823826 ↗
• 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 11,49 UG/L AND 33,86 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 16811608 ↗
• 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 26,47 UG/L AND 35,22 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 16811523 ↗
• InjuryApr 25, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP BHR RESURFACING ON (B)(6) 2010 DUE TO UNSPECIFIED COMPLICATIONS CAUSED BY HIGH IMPACT ACTIVITIES (CONSTRUCTION WORK), THE PATIENT EXPERIENCED HIGH LEVELS OF LEAD AND COBALT. ON (B)(6) 2022, AN MRI REVEALED A FAULTY HIP CONSTRUCT AND COEXISTENT METAL SHAVINGS. THIS EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023.

  Patient problems: High metal ion levels; Infiltration into Tissue

  MAUDE report 16808546 ↗
• InjuryAug 1, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER RIGHT HIP BHR SURGERY WAS PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED RIGHT HIP PAIN AND ELEVATED SERUM METAL IONS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022. DURING THIS SURGERY, A COPIOUS AMOUNT OF DARK/BLACK SOFT TISSUE WAS NOTICED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15142430 ↗
• InjuryJul 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY RIGHT BHR SURGERY PERFORMED OF (B)(6) 2005, THE PATIENT PRESENTED FEMORAL NECK OSTEOLYSIS. THIS ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022. THE PATIENT WAS PLACED IN LATERAL POSITION AND POSTERIOR APPROACH USED TO REVISE THE BHR. FEMORAL NECK RESECTED AND PRIMARY STEM WITH BHR DUAL MOBILITY LINER IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 15136791 ↗
• InjuryJul 24, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER BIRMINGHAM HIP RESURFACING PROCEDURE IN THE LEFT HIP ON THE (B)(6) 2009 DUE TO THE PATIENT DEGENERATIVE JOINT DISEASE, THE PATIENT UNDERWENT A SURGICAL INTERVENTION. THE PATIENT EXPERIENCED LEFT TOTAL HIP INFECTION AND METAL ON METAL PSEUDOTUMOR OF THE PELVIS. THIS INTERVENTION PERFORMED ON (B)(6) 2021 CONSISTED OF AN IRRIGATION AND DEBRIDEMENT WITH ANTIBIOTIC BEADS PLACEMENT. DURING THIS PROCEDURE, THE BHR RESURFACING HEAD AND ACETABULAR CUP WERE EXCISED AND A PULSE LAVAGE WITH ANTIBIOTIC SALINE AND IRRICEPT WAS PERFORMED, ALONG WITH ANTIBIOTIC BEADS PLACED IN THE ACETABULAR/HIP DEFECT. THE PATIENT WAS TRANSFER TO RECOVERY ROOM IN STABLE CONDITION. NO FURTHER INFORMATION IS AVAILABLE TO DETERMINE IF A SECOND STAGE WAS PERFORMED TO IMPLANT A NEW PROSTHESIS.

  Patient problems: Metal Related Pathology; Unspecified Infection

  MAUDE report 15090642 ↗
• InjuryJun 28, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2007, THE PATIENT EXPERIENCED PAIN LOCALIZED IN THE GROIN AREA AND CENTER OF THE LEFT BUTTOCK, LEG LENGTH DISCREPANCY OF APPROXIMATELY 5MM, ELEVATED METAL ION LEVELS, ADVERSE REACTION TO METALLIC DEBRIS, OSTEOLYSIS OF THE PROXIMAL FEMUR AND RETROACETABULAR REGION AND PATHOLOGIC INTERTROCHANTERIC FRACTURE AT THE TIP OF THE RESURFACING HEAD. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, BOTH THE BHR ACETABULAR CUP AND FEMORAL RESURFACED HEAD WERE EXPLANTED AND REPLACED WITH A COMPETITOR¿S THR SYSTEM. THE PATIENT¿S OUTCOME IS NOT KNOWN.

  Patient problems: Bone Fracture(s); Metal Related Pathology; Osteolysis; Unequal Limb Length

  MAUDE report 14847119 ↗

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-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-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-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. 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-0023-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. 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-0033-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. 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-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component.

…and 14 more.