BIRMINGHAM HIP RESURFACING (BHR) 74123152Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 03596010552433), received between Aug 2, 2017 and Dec 19, 2025 — classified as 37 injuries.

The most frequently reported specific device problem is “Biocompatibility” (23 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, DURING A BHR SURGERY PERFORMED TO THE PLAINTIFF ON (B)(6) 2011 IT WAS NOTICED THAT THE PATIENT HAD EXTREMELY HARD ACETABULAR BONE WITH SUBCHONDRAL SCLEROSIS LAYER, BEING ALMOST 9-10MM THICK. THIS REQUIRED EXTENSIVE REAMING TO GAIN ANY BLEEDING BED. AFTER THIS, THE PATIENT EXPERIENCED A PROGRESSIVE PAIN AND A LARGE CYST WAS NOTICED IN AN MRI ON (B)(6) 2024. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO A LOOSE FEMORAL COMPONENT AND THE PAIN MENTIONED. THE ACETABULAR COMPONENT AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH S+N IMPLANTS (9 STANDARD POLARSTEM, 40MM +8 OXINIUM HEAD, 60/40 +0 DEGREE POLYETHYLENE LINER AND 60MM REDAPT REVISION ACETABULAR CUP). THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aseptic loosening; Cyst(s); Implant Pain

  MAUDE report 23849600 ↗
• InjuryApr 28, 2025Migration; Migration

  IT WAS REPORTED THAT, AFTER A BHR SURGERY HAD BEEN PERFORMED ON 2020, ON (B)(6) 2025 IT WAS NOTICED BY X- RAYS THAT THE (1) FEMORAL HEAD 52MM MIGRATED. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS SOLVED NOR THE ACTIONS TAKEN TO TREAT IT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21918857 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR ON (B)(6) 2019 DUE TO AVN, THE PATIENT'S HEAD CONTINUED TO DIE AND COLLAPSED AS HIS AVN PROGRESSED. THIS CAUSED GROIN PAIN TO THE PATIENT AND THE HEAD TO SLIGHTLY SHIFT. IMPLANTS HAD BEEN PERFORMING WELL UNTIL THAT POINT. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, THE BHR RESURFACING FEMORAL HEAD 52MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Necrosis; Pain

  MAUDE report 20669604 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A HIP RESURFACING SURGERY, THE PATIENT EXPERIENCED A PAINFUL HIP 4 YEARS POST-OPERATION. THIS ADVERSE EVENT WAS TREATED CONVERTING THE RESURFACING SYSTEM TO A BDMH. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 19279077 ↗
• InjuryMar 7, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A BHR RESURFACING SURGERY PERFORMED ON (B)(6) 2007, THE PATIENT PRESENTED PAIN, LUCENCIES IN THE FEMORAL NECK REGION, AND ELEVATED LEVELS OF METAL IONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO CHANGE IT TO TOTAL HIP ARTHROPLASTY, EXPLANT THE CUP AND FEMORAL HEAD, AND REPLACE THEM WITH COMPETITOR IMPLANTS. THERE WERE SIGNS OF BLACK MATERIAL (METALLOSIS) WITH PSEUDOTUMOR, SIGNIFICANT OSTEOLYSIS OF THE SUPERIOR-LATERAL ASPECT OF THE NECK WITH COMPROMISED BONE IN THIS REGION, A LARGE GRATER TROCHANTERIC BURSA AND A SIGNIFICANT HYPERTROPHIC SYNOVIUM. NO INFECTION WAS NOTED. A SYNOVECTOMY AND BURSECTOMY WERE PERFORMED, AND THE PSEUDOTUMOR WAS EXCISED. THE CURRENT PATIENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; High metal ion levels; Metal Related Pathology; Radiolucent Lines

  MAUDE report 18857037 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, A PLAINTIFF WITH LEFT HIP DEGENERATIVE ARTHRITIS, UNDERWENT A PRIMARY BHR PROCEDURE ON (B)(6) 2012. AFTER EXPERIENCING PERSISTENT PAIN THEY HAD A REVISION SURGERY ON (B)(6) 2023, DUE TO FAILURE OF THE RESURFACING PROCEDURE, NO EVIDENCE OF INFECTION OR METALLOSIS WAS FOUND. CEMENT DEBONDING ON THE UNDERSURFACE OF THE FEMORAL CAP WAS NOTICED. BOTH RESURFACING COMPONENTS WERE REPLACED BY A ZIMMER TOTAL HIP SYSTEM. THE PATIENT WAS TRANSFERRED TO PACU WITHOUT COMPLICATIONS. NO OTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Arthralgia; Failure of Implant; Synovitis

  MAUDE report 17957172 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A PRIMARY LEFT BHR SURGERY ON (B)(6) 2009, DUE TO HIP PAIN RELATED TO DYSPLASIA WITH SECONDARY OSTEOARTHRITIS FROM A CHILDHOOD FEMORAL FRACTURE. THEN THEY WERE DIAGNOSED WITH A KNEE INFECTION; THEREFORE, A TWO-STAGE REVISION SURGERY WAS PLANNED. THE FIRST STAGE WAS PERFORMED ON (B)(6) 2013, TO REMOVE THE BHR CUP AND FEMORAL HEAD, AND IRRIGATE AND DEBRIDE THE WOUND. WHEN THE CAPSULE WAS INCISED, FRANK GRAY PUS WAS EXPRESSED, AND CYSTS WERE FOUND WITHIN THE DOME OF THE ACETABULUM. AN ANTIBIOTIC IMPREGNED CEMENT WAS USED TO CREATE A CEMENT SPACER. THE PATIENT WAS LATER TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. NO INFORMATION HAS BEEN MADE AVAILABLE REGARDING THE SECOND REVISION. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cyst(s); Unspecified Infection

  MAUDE report 17685069 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING (B)(6) 2013, THE PATIENT WAS PLAYING GOLF AND FELT A SNAP AND A POP IN HIS LEFT HIP. X-RAYS SHOWED A GREAT TROCHANTERIC AVULSION INJURY. THE PATIENT UNDERWENT AN ORIF FIXATION SURGERY ON (B)(6) 2013. AT THE TIME OF THIS ADVERSE EVENT, THE PATIENT HAD A BHR SYSTEM IMPLANTED IN HIS LEFT HIP. THE PRIMARY LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2009.

  Patient problems: Hip Fracture

  MAUDE report 17514399 ↗
• InjuryMay 19, 2023Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT HIP BHR RESURFACING ON (B)(6) 2015, THE PATIENT EXPERIENCED PAIN, OSTEOLYSIS AND FEMORAL COMPONENT LOOSENING. SUBSEQUENTLY ON (B)(6) 2017, ELEVATED METAL LEVELS IN BLOOD WERE FOUND (COBALT = 12.2 G/L, CHROMIUM = 9.8 G/L). THESE EVENTS WERE TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2020, IN WHICH THE FEMORAL HEAD WAS EXPLANTED, AND THE CUP WAS RETAINED. A SMITH+NEPHEW THA SYSTEM WAS PLACED, COMPOSED BY A SYNERGY STEM, AN OXINIUM FEMORAL HEAD AND A BHR DUAL MOBILITY INSERT.

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

  MAUDE report 16965412 ↗
• InjuryMay 15, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A RIGHT BHR PROCEDURE WAS PERFORMED ON THE (B)(6) 2012, THE PATIENT WAS PRESENTED WITH A FAILED BHR SYSTEM WITHOUT FURTHER INFORMATION. THE PATIENT UNDERWENT A REVISION SURGERY ON THE (B)(6) 2022. DURING THE PROCEDURE IT WAS FOUND THAT THE RIGHT LEG WAS SHORTER BY 1 CM. THE PATIENT RECEIVED A THA SYSTEM IN EXCHANGE, THE ACETABULAR COMPONENT WAS MAINTAINED. THE PATIENT WAS THEN TAKEN TO THE RECOVERY ROOM.

  Patient problems: Extraskeletal ossification; High metal ion levels; Inadequate Osseointegration; Insufficient Information; Unequal Limb Length

  MAUDE report 16936524 ↗
• InjuryMar 13, 2023Malposition of Device; Biocompatibility; Malposition of Device; Biocompatibility

  IT WAS REPORTED THAT AFTER A BHR RESURFACING LEFT HIP SURGERY WAS PERFORMED DUE TO OSTEOARTHRITIS ON (B)(6)2015 THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6)2021 WHERE THE FEMORAL COMPONENT WAS EXPLANTED. THE PATIENT PRESENTED PAIN AND MECHANICAL SYMPTOMS CONSISTENT WITH IMPINGEMENT. DIFFICULTY FLEXING AND INTERNALLY ROTATING HIS LEG AND SERUM METAL ION LEVELS WERE ALSO ELEVATED. DURING SURGERY WAS NOTICED THAT THE FEMORAL HEAD WAS FLEXED ANTERIORLY. THE PATIENT WAS TRANSPORTED TO THE POST-ANESTHESIA CARE UNIT (PACU) WITHOUT INCIDENT AFTER THE SURGERY.

  Patient problems: Arthralgia; High metal ion levels; Implant Pain; Infiltration into Tissue; Joint Impingement; Loss of Range of Motion

  MAUDE report 16527348 ↗
• InjuryDec 13, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED PAIN OVER THE COURSE OF THE LAST YEAR. MRI REVEALED SOME FLUID COLLECTION AROUND THE IMPLANTS. CO WAS 3.7UG/L (TEST MENTIONED RESULTS FROM NON-CERTIFIED TEST KIT DUE TO BACKORDERS) AND CR WAS 3.0UG/L. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A BHR RESURFACING FEMORAL HEAD 52MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Infiltration into Tissue; Pain

  MAUDE report 15974798 ↗
• InjuryJun 4, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN UNSPECIFIED METAL ON METAL HIP CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2016. THE PATIENT SUSTAINED AN UNSPECIFIED INJURY AND REQUIRED A REVISION SURGERY ON (B)(6) 2021. THE IDENTITY OF THE EXPLANTED DEVICES AND THE PROSTHESIS IMPLANTED IN EXCHANGE IS UNKNOWN. THE PATIENT¿S OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 14599400 ↗
• 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 14054680 ↗
• 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 14007696 ↗
• InjuryApr 1, 2022Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth

  *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 13975783 ↗
• 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 13896522 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ''US LEGAL'': IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A PRIMARY BHR SURGERY IN HIS RIGHT HIP ON (B)(6) 2012 DUE TO OSTEOARTHRITIS. IMMEDIATE POST-OPERATIVE RADIOGRAPH REVEALED A SUBLUXATION OF THE FEMORAL HEAD ANTERIORLY DUE TO THE PATIENT'S DENSE NEUROMUSCULAR BLOCK SECONDARY TO REGIONAL ANESTHETIC. A CLOSE REDUCTION WAS PERFORMED IN THE PACU TO SOLVE THIS ADVERSE EVENT. POSTOPERATIVE RADIOGRAPH REVEALED NO FRACTURES, DISLOCATIONS AND APPROPRIATELY POSITIONED COMPONENTS.

  Patient problems: Joint Dislocation

  MAUDE report 13758778 ↗
• InjuryMar 11, 2022Biocompatibility; Biocompatibility

  *US LEGAL* IT WAS REPORTED THAT AFTER A PRIMARY LEFT BHR RESURFACING SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED CONTINUED PAIN. AN MRI PERFORMED ON (B)(6) 2018 REVEALED DEEP TISSUE SWELLING AND LATERAL SOFT TISSUE SWELLING. PATIENT ALSO HAD ELEVATED COBALT AND CHROMIUM LEVELS IN BLOOD. THE PLAINTIFF¿S SURGEON INDICATED THE NEED FOR A REVISION SURGERY DUE TO METALLOSIS AND EXTENSIVE SYNOVITIS. THE LEFT HIP REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 AND THE HIP WAS REPLACED TO A THA FROM AN UNKNOWN MANUFACTURER. UNFORTUNATELY, AFTER THE REVISION SURGERY, THE PLAINTIFF KEPT EXPERIENCING SEVERAL ADVERSE EVENTS, REQUIRING 2 ADDITIONAL REVISION SURGERIES. THE PATIENT CURRENTLY HAS LEFT HIP PAIN, CHRONIC DYSFUNCTION, SOFT TISSUE SCARRING AND MECHANICAL ISSUES DUE TO METALLOSIS.

  Patient problems: Arthralgia; Bursitis; High metal ion levels; Metal Related Pathology; Synovitis; Unspecified Tissue Injury

  MAUDE report 13733829 ↗
• InjuryDec 20, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT BHR ON (B)(6) 2020 THE PLAINTIFF HAS SUFFERED OF PERSISTENT AND EXTENSIVE LEFT HIP PAIN WITH LEFT LEG WEAKNESS, FLUID COLLECTION IN THE SOFT TISSUE OF THE LEFT HIP, AND FAILURE OF LEFT HIP RESURFACING WITH ALVAL CONSISTENT WITH METALLOSIS. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2021 WHERE THE INTRA-OPERATIVE FINDINGS SHOWED FAILED TOTAL HIP RESURFACING WITH ALVAL AND TISSUE NECROSIS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 13046805 ↗
• 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 12778818 ↗
• InjurySep 29, 2021Biocompatibility; Biocompatibility

  *US LEGAL MDL* IT WAS REPORTED THAT, AFTER A PRIMARY BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S RIGHT HIP ON (B)(6) 2014, THE PLAINTIFF EXPERIENCED METALLOSIS, PSEUDOTUMOR FORMATION, LOSS OF MOBILITY, STIFFNESS AND SEVERE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF¿S OUTCOME IS UNKNOWN.

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

  MAUDE report 12548182 ↗
• InjurySep 27, 2021Biocompatibility; Biocompatibility

  US LEGAL MDL. IT WAS REPORTED THAT, AFTER A PRIMARY BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S RIGHT HIP ON (B)(6) 2010, THE PLAINTIFF EXPERIENCED PAIN, LIMITED MOBILITY AND METAL STAINING OF THE SYNOVIUM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF¿S OUTCOME IS UNKNOWN.

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

  MAUDE report 12537234 ↗
• InjurySep 14, 2021Loss of Osseointegration; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2018, THE PLAINTIFF EXPERIENCED SEVERE PAIN, DISCOMFORT, INFLAMMATION AROUND THE HIP IMPLANTS, AND ELEVATED BLOOD METAL ION LEVELS. THIS EVENT IS AN ISSUE THAT STARTED ON (B)(6) 2021. THE PLAINTIFF INITIALLY HAD RESOLUTION OF PAIN AFTER SURGERY, BUT BACK ON (B)(6) 2021 HE DEVELOPED NEW ONSET GROIN PAIN. ON (B)(6) 2021, HE HAD A FEMORAL COMPONENT THAT WAS SHORTENED AND IN VARUS COMPARED TO HIS IMMEDIATE POST-OP FILMS, AND AN ACETABULAR COMPONENT THAT HAD MIGRATED MEDIALLY AND PROXIMALLY COMPARED TO IMMEDIATE POST-OP FILMS. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 TO ADDRESS THE ISSUE. BOTH BHR COMPONENTS WERE EXPLANTED AND REPLACED WITH A THR SYSTEM FROM A COMPETITOR. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Arthritis; Discomfort; Inadequate Osseointegration; Infiltration into Tissue; Joint Laxity; Metal Related Pathology

  MAUDE report 12472002 ↗
• InjuryMay 31, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2010, THE PATIENT EXPERIENCED METALLOSIS OR ELEVATED METAL IONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE FEMORAL HEAD 52MM WAS EXPLANTED DURING THIS SURGERY AND IT WAS REPLACED WITH A BHR DUAL MOBILITY INSERT FROM SMITH AND NEPHEW. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 11907579 ↗

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-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-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-0029-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. 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-0032-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. 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-0016-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. 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-0027-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component.

…and 14 more.