BIRMINGHAM HIP RESURFACING (BHR) 74120154Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 03596010502582), received between May 16, 2017 and Mar 17, 2026 — classified as 2 deaths, 68 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (17 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 70 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT BHR PERFORMED ON (B)(6) 2008, PATIENT WAS HOSPITALIZED DUE TO CELLULITIS AROUND THE PERIOPERATIVE SITE ON (B)(6) 2008. THIS ADVERSE EVENT WAS TREATED WITH KEFLEX. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Cellulitis

  MAUDE report 24624250 ↗
• InjuryJul 24, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR SURGERY PERFORMED ON (B)(6) 2009, IN WHICH A ACETLR CUP HAP 54MM W/ IMPTR AND A RESURFACING FEMORAL HEAD 46MM WERE IMPLANTED, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 DUE TO PAIN AND HIGH BLOOD COCR LEVELS. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 22587774 ↗
• InjuryJun 5, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT BHR SYSTEM ON (B)(6) 2014, THE PATIENT EXPERIENCED HIGH COCR LEVELS IN BLOOD. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH S+N IMPLANTS WERE EXPLANTED AND REPLACED FOR COMPETITOR IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: High metal ion levels; Metal Related Pathology

  MAUDE report 22155304 ↗
• InjuryMay 15, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR-THA IN HIS LEFT HIP JOINT ON (B)(6) 2008, PATIENT EXPERIENCED FAILED LEFT TOTAL HIP ARTHROPLASTY DUE TO METALLOSIS. HE HAD NO PAIN ASSOCIATED WITH THE PROTHESIS, HOWEVER, HAD ELEVATED METAL ION LEVELS. HIS METAL ION LEVELS HAVE STEADILY GONE UP. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY. DURING PROCEDURE, IT WAS NOTED THERE WAS A SLIGHT METALLIC TINGE TO THE SYNOVIAL TISSUE, AND A FULL SYNOVECTOMY WAS PERFORMED. THEN, REMOVED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL COMPONENT, AND THE GREATER TROCHANTER. THE PATIENT HAD AN ABDUCTION PILLOW PLACED. PATIENT WAS EXTUBATED. THE PATIENT WAS TAKEN TO THE PACU IN STABLE CONDITION.

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

  MAUDE report 22026960 ↗
• InjuryMay 9, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT FOLLOWING A BIRMINGHAM HIP RESURFACING (BHR) PROCEDURE PERFORMED ON (B)(6) 2012 IN THE PATIENT¿S RIGHT HIP JOINT WHERE A ACETLR CUP HAP 54MM W/ IMPTR WAS IMPLANTED, THE PATIENT EXPERIENCED PERSISTENT PAIN IN THE RIGHT GROIN AND THIGH. COBALT LEVELS WERE ELEVATED AT 1.7, WHILE CHROMIUM LEVELS REMAINED WITHIN NORMAL RANGE. MRI IMAGING REVEALED OSTEOLYSIS WITHIN THE FEMORAL NECK AND INTERTROCHANTERIC REGION, CONSISTENT WITH METALLOSIS POST RIGHT BHR. THIS ADVERSE EVENT WAS ADDRESSED THROUGH REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE SURGEON CONVERTED THE IMPLANT TO A TOTAL HIP ARTHROPLASTY. METAL-STAINED AND SYNOVITIC TISSUE WAS IDENTIFIED AND DEBRIDED INTRAOPERATIVELY. THE PATIENT EMERGED FROM ANESTHESIA WITHOUT ISSUE AND WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT (PACU) IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 21997762 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THE PATIENT UNDERWENT A LEFT METAL-ON-METAL BHR THA ON (B)(6) 2009, WOKE UP ON (B)(6) 2023 WITH FEVER, LEFT SIDED NON-TRAUMATIC HIP PAIN AND WAS UNABLE TO MOVE, WALK OR BEAR WEIGHT. AN ASPIRATION WAS PERFORMED ON (B)(6) 2023 WHICH CONFIRM A STAPH LUGDUNENSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 DUE TO INFECTION. SIGNIFICANT PUS WAS FOUND THROUGHOUT THE HIP JOINT AND INTO THE ILIAC FOSSA, TRACKING DISTALLY TO BELOW THE LESSER TROCHANTER. THE HIP WAS WASHED OUT AND PREVIOUS ACETLR CUP HAP 54MM W/ IMPTR AND RESURFACING FEMORAL HEAD 46MM WERE EXPLANTED. COMPETITOR IMPLANTS (ZIMMER) WERE IMPLANTED IN ORDER TO REPLACE THE REMOVED IMPLANT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: High metal ion levels; Loss of Range of Motion; Medical device site infection; Osteolysis; Pain

  MAUDE report 21580171 ↗
• InjuryNov 19, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHR RESURFACING TO BHR-THA CONVERSION IN HIS LEFT HIP JOINT ON (B)(6) 2007 DUE TO LEFT FEMORAL NECK FRACTURE, THE PATIENT EXPERIENCED PAIN, AN ADVERSE TISSUE REACTION TO METAL DEBRIS AND A PSEUDOTUMOR IN THE HIP JOINT. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Discomfort; Metal Related Pathology; Pain; Solid Tumor; Unequal Limb Length

  MAUDE report 20728264 ↗
• InjuryJul 4, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP RESURFACING (BHR) ON (B)(6) 2007 DUE TO DEGENERATIVE JOINT DISEASE. PATIENT SUFFERED FROM FAILED LEFT HIP RESURFACING, ASEPTIC LOOSENING, AND ADVERSE LOCAL SOFT TISSUE REACTION. PATIENT WAS EXPERIENCING PAIN TO THE POINT WHERE HE WALKED WITH PLATFORM CRUTCHES AND COULD NOT WALK MORE THAN HALF A BLOCK. IN ADDITION, DEVELOPED ELEVATED CO CR LEVELS. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2023, DURING WHICH BOTH RESURFACING COMPONENTS WERE EXPLANTED. DURING PROCEDURE THEY ENCOUNTERED GREAT DEAL OF FIBROUS TISSUE, SYNOVIUM STAINED WITH METAL AS WELL AS MURKY FLUID CONSISTENT WITH METALLOSIS REACTION. ALSO, THEY PERFORATED THE ANTERIOR NECK AS THE STEM HAD BROKEN THROUGH, HOWEVER, THERE WAS NO FRACTURE THAT EXTENDED DOWN TO THE CALCAR ANYWHERE IN THE PROXIMAL FEMUR. CONVERSION TO A COMPETITOR'S THA SYSTEM (STRYKER) USING INTELLIJOINT NAVIGATION SYSTEM WAS SUCCESSFULLY PERFORMED. LEG LENGTH RESTORATION WAS CHECKED AND FOUND TO BE NORMALIZED BOTH CLINICALLY AND WITH THE USE OF POSTOPERATIVE AP PELVIS X-RAY. THE PATIENT WAS THEN TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 19674959 ↗
• InjuryJan 18, 2024Biocompatibility; Migration; Biocompatibility; Migration

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED METALLOSIS AND IMPLANT MOBILIZATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENTS STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 18536837 ↗
• 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 CUP LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY TO A BHR DYSPLASIA CUP 97 MONTHS AFTER IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16820483 ↗
• InjuryMar 30, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER RIGHT HIP RESURFACING SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO OSTEOARTHRITIS, THE PATIENT ALLEGED POSSIBLE METALLOSIS, PAIN AND HIP POPPING SOUND. EVEN THOUGH THE X-RAYS LOOK NORMAL ACCORDING TO HIS DOCTOR, THE SYMPTOMS PERSIST. THIS EVENT HAS NOT BEEN TREATED YET. BLOOD TESTS COLLECTED ON (B)(6) 2022 SHOW THAT THE METAL LEVELS ARE COBALT = 3.7G/L AND CHROMIUM = 4.0G/L. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Implant Pain

  MAUDE report 16650027 ↗
• InjuryMay 27, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON (B)(6) 2008, THE PATIENT EXPERIENCED PAIN, ELEVATED METAL ION LEVELS AND A REDUCED MOBILITY OF HIS LEFT HIP. ON X-RAYS, MULTIPLE AREAS OF LUCENCY INVOLVING THE SUPERIOR ACETABULAR DOME AS WELL AS THE ISCHIUM WERE NOTED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, A LARGE DEFECT ON THE POSTERIOR WALL EXTENDING INTO THE ISCHIUM WAS NOTED, AND THIS WAS CONSISTENT WITH THE X-RAY FINDINGS PERFORMED BEFORE THE REVISION SURGERY. INTRAOPERATIVELY, THIS DEFECT WAS PACKED WITH THE ACETABULAR BONE AUTOGRAFT AS WELL AS BONE FROM THE FEMORAL NECK, ALONG WITH BONE GRAFT TO FILL SMALLER DEFECTS IN THE DOME. PER SURGEON¿S JUDGEMENT, THESE FINDINGS WERE SUGGESTIVE OF CHRONIC INFLAMMATION WITH PIGMENTATION LIKELY FROM METALLOSIS. THE ACETABULAR CUP AND THE RESURFACING FEMORAL HEAD WERE WELL FIXED, AND THEY WERE REMOVED WITH MINIMAL BONE LOSS TO IMPLANT A THR SYSTEM. THE PATIENT TOLERATED WELL THE PROCEDURE AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

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

  MAUDE report 14527254 ↗
• InjuryMay 27, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2007, THE PATIENT EXPERIENCED DISABLING RIGHT HIP PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, A MINIMAL DARK/METAL-STAINED TISSUE WAS EVIDENT WHILST PERFORMING THE SYNOVECTOMY. THE BHR RESURFACING FEMORAL HEAD WAS RESECTED AFTER A CUT HAD BEEN PERFORMED ON THE FEMORAL NECK, AND THE ARTICULATION WAS REPLACED WITH A THR SYSTEM COMBINING AN OXINIUM FEMORAL HEAD AND A BHR DUAL MOBILITY INSERT. THE PATIENT WAS EXTUBATED AND THEN TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Arthralgia; Metal Related Pathology

  MAUDE report 14526948 ↗
• InjuryApr 1, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT AFTER A PRIMARY LEFT HIP BHR SURGERY PERFORMED ON (B)(6) 2007, THE PLAINTIFF UNDERWENT A LEFT HIP REVISION SURGERY ON (B)(6) 2021 DUE TO PAIN, WEAKNESS, SEVERELY ELEVATED SERUM ION LEVELS AND ADVERSE LOCAL TISSUE REACTION. DURING THE REVISION, BOTH BHR RESURFACING COMPONENTS WERE EXPLANTED AND REPLACED WITH A THA SYSTEM FROM A COMPETITOR. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Metal Related Pathology

  MAUDE report 13982082 ↗
• InjuryMar 17, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR-THA ON THE RIGHT HIP ON (B)(6) 2008 DUE TO OSTEOARTHRITIS, THE PLAINTIFF BEGAN EXPERIENCING PAIN AND ELEVATED METAL LEVELS. PLAINTIFF UNDERWENT REVISION SURGERY ON HIS RIGHT HIP ON (B)(6) 2018, WHERE SOME SYNOVIAL DEBRIS WERE NOTED. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 13794608 ↗
• InjuryAug 9, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY BHR THA CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF'S RIGHT HIP ON (B)(6) 2011, THE PLAINTIFF EXPERIENCED ELEVATED METAL ION LEVELS IN BLOOD AND METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ISSUE. DURING THIS PROCEDURE, THE MODULAR HEAD AND THE SLEEVE WERE EXPLANTED AND REPLACED WITH AN XLPE DUAL MOBILITY INSERT AND AN OXINIUM FEMORAL HEAD. INTRAOPERATIVELY, THERE WAS A LIGHT METAL STAINING IN THE CAPSULE. A SMALL AMOUNT OF FLUID CONSISTENT WITH NORMAL JOINT FLUID WAS ALSO ENCOUNTERED. THE PROSTHESIS WAS VISUALIZED, AND THE OUTER BALL OF THE METAL-ON-METAL BEARING APPEARED PRISTINE. THERE AS A MODERATE CORROSION BETWEEN THE MODULAR HEAD AND THE SLEEVE, AND A MODERATE CORROSION BETWEEN THE SLEEVE AND THE STEM. THE PATIENT HAS BEEN RECOVERING FROM SURGERY WITHOUT ANY ADDITIONAL COMPLICATIONS.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 12298268 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL: IT WAS REPORTED THAT ELEVATED COBALT AND CHROMIUM LEVELS WERE DETECTED IN THE RIGHT HIP. THE PATIENT¿S TEST RESULTS INDICATED ELEVATED ION LEVELS EVEN AFTER THE REVISION SURGERY OF THE LEFT BHR HIP SYSTEM (COVERED UNDER (B)(4)). IT WAS NOT REPORTED IF A REVISION SURGERY IS PLANNED FOR THIS PATIENT.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 11999868 ↗
• InjuryMay 26, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  *US LEGAL MDL*. IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF LEFT HIP ON (B)(6) 2008, THE PLAINTIFF EXPERIENCED BROWN-TANNISH SYNOVITIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Synovitis

  MAUDE report 11891201 ↗
• InjuryMay 26, 2021Biocompatibility; Biocompatibility

  US LEGAL MDL. IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF RIGHT HIP ON (B)(6) 2007, THE PLAINTIFF EXPERIENCED PAINT, LIMITED MOBILITY AND GREY LEATHERY METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF OUTCOME IS UNKNOWN.

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

  MAUDE report 11891200 ↗
• InjuryMar 26, 2021Adverse 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 MEDICALLY INDICATED REVISION OF THE BHR-THA RIGHT HIP ON (B)(6) 2020 DUE TO RECURRENT DISLOCATIONS AND METALLOSIS. AMONG THE INTRAOPERATIVE FINDINGS THERE WAS A SEVERE METALLOSIS WITH A SOFT TISSUE REACTION, PSEUDOTUMOR AND SEVERE ACETABULAR BONE LOSS. THE STEM WAS RETAINED AND A NEW S&N OXONIUM HEAD WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 11574593 ↗
• InjuryFeb 24, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON LEFT HIP ON (B)(6) 2018. THE REVISION WAS PERFORMED DUE TO PAIN, LIMITED MOBILITY, AND ELEVATED METAL ION LEVELS. ON THE RIGHT SIDE FOLLOWING PRIMARY SURGERY.

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

  MAUDE report 11376191 ↗
• InjuryFeb 23, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND REVISION SURGERY ON THE LEFT HIP ON (B)(6) 2018. THE REVISION WAS PERFORMED DUE TO PAIN, LIMITED MOBILITY, AND ELEVATED METAL ION LEVELS ON THE RIGHT SIDE FOLLOWING PRIMARY SURGERY. THE PATIENT OUTCOME IS UNKNOWN AS WELL AS WHICH DEVICES WERE IMPLANTED DURING PREVIOUS REVISION SURGERY.

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

  MAUDE report 11366362 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLAINTIFF UNDERWENT MEDICALLY-INDICATED REVISION OF THE BHR RIGHT HIP IMPLANTS ON (B)(6) 2018. THE PATIENT REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN, FAILED RIGHT HIP RESURFACING, STIFFNESS, LOSS OF MOBILITY, METALLOSIS, PSEUDOTUMOR, NECROSIS, AND ADVERSE TISSUE REACTION. THE CUP AND HEAD WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

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

  MAUDE report 10909465 ↗
• InjuryOct 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A BHR CONSTRUCT HAD BEEN IMPLANTED ON THE LEFT SIDE, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT. ALTHOUGH THE PATIENT HAS NOT UNDERGONE A REVISION SURGERY YET, ON (B)(6) 2020 IT WAS CONFIRMED THROUGH THE MEDICAL RECORDS THAT THE PATIENT WAS DIAGNOSED WITH ELEVATED METAL IONS ON (B)(6) 2016: IONS LEVELS OF COBALT IN BLOOD OF 10.9 MCG/L, AND CHROMIUM IN BLOOD 2.7 MCG/L, WHICH ARE DEEMED TOXIC TO THE ORGANISM. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 10718907 ↗
• InjurySep 10, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A BILATERAL PATIENT (THIS SIDE RIGHT) PRESENTED METALLOSIS. PATIENT WAS REVISED FOR LEFT SIDE AND REPORTED VIA MDR 3005975929-2020-00122.

  Patient problems: Test Result

  MAUDE report 10513092 ↗

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-0026-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. 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-0023-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. 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-0016-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. 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-0031-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. 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-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component.

…and 14 more.