BHRRecalls & reported problems across all models

We found 10 models of BHR by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 177 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2017 and Oct 8, 2025 — classified as 177 injuries.

The most frequently reported specific device problem is “Biocompatibility” (96 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BHR problems

BHR models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BHR 74122550

  Prosthesis, hip, hemi-, femoral, metal
  45 reports
• BHR 74122546

  Prosthesis, hip, hemi-, femoral, metal
  40 reports
• BHR 74122542

  Prosthesis, hip, hemi-, femoral, metal
  23 reports
• BHR 74122548

  Prosthesis, hip, hemi-, femoral, metal
  22 reports
• BHR 74122544

  Prosthesis, hip, hemi-, femoral, metal
  13 reports
• BHR 74122554

  Prosthesis, hip, hemi-, femoral, metal
  13 reports
• BHR 74122552

  Prosthesis, hip, hemi-, femoral, metal
  10 reports
• BHR 74122540

  Prosthesis, hip, hemi-, femoral, metal
  7 reports
• BHR 74122538

  Prosthesis, hip, hemi-, femoral, metal
  3 reports
• BHR 74122556

  Prosthesis, hip, hemi-, femoral, metal
  1 report

Recent BHR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING A BHR-THA ON (B)(6) 2012, THE PATIENT EXPERIENCED HIP PAIN THAT PROGRESSIVELY GOT WORSE, WITH A PAINFUL CLICKING SENSATION. LABORATORY TESTS SHOWED ELEVATED CHROMIUM AND COBALT LEVELS. ALSO, X-RAYS HAVE SHOWN SOME BONE LOSS. THEREFORE, ON 0(B)(6) 2025, A REVISION SURGERY WAS PERFORMED DUE TO THE MECHANICAL COMPLICATIONS AND THE METALOSIS WITH CHRONIC INFLAMMATION FROM METAL-ON-METAL. DURING THIS REVISION SURGERY, THE SYSTEM WAS CONVERTED TO DUAL MOBILITY HIP SYSTEM, SO THE ACETABULAR CUP HAP SIZE 44/50 AND THE BHR MODULAR HEAD 44MM WERE EXPLANTED. OSTEOLYSIS WAS FOUND IN THE POSTERIOR ASPECT OF THE FEMUR, AS WELL AS THE ANTERIOR JUNCTION WITH THE PUBIC RAMI. A SYNOVECTOMY OF THE STAINED METALLOSIS SYNOVIUM ALL AROUND THE HIP WITH SHARP DISSECTION AND CAUTERY FOR HEMOSTASIS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM, HAVING TOLERATED THE PROCEDURE WELL.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 23245538 ↗
• InjuryOct 6, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING A BHR-THA ON (B)(6) 2011 DUE TO A FAILED LEFT HIP RESURFACING. PATIENT SUFFERED FROM METAL-ON-METAL DISEASE. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH SURGEON DID A HEAD EXCHANGE AND CONVERSION TO A DUAL MOBILITY. UPON INSPECTING THE SOFT TISSUE STRUCTURE, THERE WAS NO EVIDENCE OF SOFT-TISSUE STRUCTURE EROSION. THE ABDUCTOR TENDONS WERE HEALTHY· APPEARING WITHOUT ANY EVIDENCE OF WEAR. THERE WAS NO PSEUDOTUMOR THAT WAS THEN VISUALIZED THROUGH THE APPROACH THAT WE WERE ABLE TO IDENTIFY. UPON ENTERING THE JOINT, THERE WAS SOME DUSKY METAL DISEASE. IT WAS NOTED PRIMARILY WHAT APPEARED TO BE FROM THE SOURCE OF TRUNNIONOSIS. THE FEMORAL HEAD WAS REMOVED, AND THE TRUNNION SLEEVE HAD SOME BACKSIDE WEAR WHERE SURGEON MATED WITH THE FEMORAL HEAD. SKIN WAS CLOSED WITH STAPLE. STERILE DRESSING WAS APPLIED. THE PATIENT WAS AWOKEN FROM GENERAL ANESTHESIA AND TRANSFERRED TO THE PACU IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 23221730 ↗
• InjuryJul 1, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER UNDERGOING A BHRMH IN HIS LEFT HIP JOINT ON (B)(6) 2010, PATIENT EXPERIENCED PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY. THEY ENCOUNTER SMALL FLUID COLLECTION AND SOME ADVERSE SOFT TISSUE REACTION. THIS WAS DEBRIDED AND IRRIGATED. ABDUCTOR TENDONS WERE INTACT WITHOUT SIGNIFICANT INVOLVEMENT. THE FEMORAL AND ACETABULAR COMPONENTS WERE SOLID. STERILE DRESSING WAS APPLIED. POSTOPERATIVE SURGICAL CHECKLIST WAS ALSO PERFORMED. FINALLY, PATIENT WAS TRANSFERRED TO PACU IN GOOD CONDITION.

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 22371728 ↗
• InjuryJun 25, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER UNDERGOING A BHRMH IN HIS RIGHT HIP JOINT ON (B)(6) 2010, PATIENT EXPERIENCED FAILURE OF RIGHT METAL-ON-METAL TOTAL HIP REPLACEMENT WITH METAL TOXICITY. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY. WHILE DOING THE PROCEDURE THEY ENCOUNTERED SIGNIFICANT AMOUNTS OF NECROTIC APPEARING SYNOVIUM WHICH WAS EXCISED. THIS WAS EXCISIONAL IN NATURE. ALSO, THERE WAS SOME DEBRIS AND CORROSION ON THE TRUNNION. FINALLY, PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Metal Related Pathology; Necrosis

  MAUDE report 22326545 ↗
• InjuryJun 24, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT BHR-THA HAD BEEN PERFORMED ON (B)(6) 2008, PATIENT EXPERIENCED FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO METALLOSIS. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, THE SURGEON CONVERTED TO TOTAL HIP ARTHROPLASTY AND THE HEMI HEAD 50MM AND THE MODULAR SLEEVE WERE EXPLANTED. IN ADDITION, DURING PROCEDURE, THE HIP WAS ASPIRATED, AND 10 CC OF CLOUDY SYNOVIAL FLUID ENCOUNTERED, CONSISTENT WITH METALLOSIS. THE CAPSULE WAS MARKEDLY THICKENED, AND DISTORTED ANATOMY WAS ENCOUNTERED GIVEN PRIOR POSTERIOR APPROACH HIP REPLACEMENT WITH SUBSEQUENT METALLOSIS. THICKENED CAPSULE WAS DEBRIDED ON THE UNDERSURFACE. THE SUPERFICIAL CAPSULE WAS TAGGED AND RETRACTED SUPERIORLY. A EXOFIN DRESSING WAS APPLIED, FOLLOWED BY A STERILE DRESSING. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TAKEN TO THE PACU IN GOOD CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 22323198 ↗
• InjuryMay 15, 2025Biocompatibility; Noise, Audible; Biocompatibility; Noise, Audible

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A RIGHT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2011, DID VERY WELL POSTOPERATIVELY UNTIL ABOUT A YEAR AGO, SUBSEQUENT TO A LUMBAR ARTHRODESIS IN LATE 2023. PATIENT HAS BEEN SUFFERING OF PAIN IN THE RIGHT HIP, WITH CLICKING. HE WAS NOTED TO HAVE MODERATE ELEVATION OF HIS SERUM CHROMIUM AND COBALT IONS CHROMIUM 3.6, COBALT 6.4, WHICH WERE TRENDING UPWARD. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, THE DEEP CAPSULE WAS EXAMINED. THERE WAS SOME DISCOLORATION OF THE DEEP CAPSULE, BROWNISH GRAY, BUT NOT EXTENSIVE. ALL OF THE MUSCLE APPEARED TO BE HEALTHY. SMALL AREAS OF CAPSULE WERE EXCISED, WHICH ALLOWED THE HIP TO BE DISLOCATED, AND THE REMAINDER OF THE QUESTIONABLE CAPSULAR AREAS TO BE EXCISED. THIS WAS THEN SENT AS A SPECIMEN TO THE PATHOLOGIST FOR EXAMINATION IN THE CASE OF POSSIBLE METALLOSIS, STATUS POST METAL-ON-METAL HIP FROM 15 YEARS AGO, WITH RECENT MODEST ELEVATION IN SERUM IONS. UPON OPENING THE CAPSULE, THERE WAS A SMALL AMOUNT OF JOINT FLUID, SLIGHTLY BROWN, NOT PURULENT, WHICH WAS SENT FOR SURVEILLANCE AEROBIC AND ANAEROBIC CULTURES TO MICROBIOLOGY LAB. PORTION OF DENSE FIBROUS AND FATTY TISSUE, AND SYNOVIUM WITH R

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 22026753 ↗
• InjuryMay 15, 2025Corroded; Biocompatibility; Corroded; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A BILATERAL METAL-ON-METAL R3 THA PERFORMED ON (B)(6) 2010, THE PATIENT PRESENTED IN (B)(6) 2024 WITH INCREASED LEFT AND RIGHT HIP PAIN, AS WELL AS MECHANICAL SYMPTOMS, AND ELEVATED COBALT/CHROMIUM ION LEVELS. MRI SHOWS EVIDENCE OF ARMD/ALTR, MORE PRONOUNCED ON THE LEFT. A REVISION SURGERY FOR THE RIGHT HIP WAS PERFORMED ON (B)(6) 2024 DUE TO A FAILED RIGHT TOTAL HIP ARTHROPLASTY, WITH EVIDENCE OF ADVERSE REACTION TO METAL DEBRIS. A SMALL AMOUNT OF INFLAMMATORY FLUID WAS FOUND, BUT NO SIGNS OF INFECTION. NUMEROUS SAMPLES WERE SENT FOR CULTURE AND ALSO FOR PATHOLOGIC ANALYSIS TO EVALUATE FOR ADVERSE REACTION TO METAL DEBRIS. ABDUCTORS WERE INTACT AND NO EVIDENCE OF BONE LOSS. THE 50 MM HEAD AND METALLIC SLEEVE WERE REMOVED. IN THE FEMORAL HEAD THERE WAS INFLAMMATORY TISSUE WITHIN THE BASE (BUT LESS THAN IN THE LEFT), WITH SIGNIFICANT BLACK METALLIC STAINING, INDICATING SIGNIFICANT CORROSION PRODUCT. WHILE TRYING TO INSPECT THE STEM, A SMALL AMOUNT OF CORROSION PRODUCT WAS NOTICED ON THE TRUNNION. THE STEM WAS RETAINED AND CORROSION WAS CLEANED. THE LINER WAS ALSO REMOVED AND INSPECTED, AND IT WAS NOTICED SIGNIFICANT CORROSION PRODU

  Patient problems: Cramp(s) /Muscle Spasm(s); Diarrhea; Dizziness; Headache; Metal Related Pathology; Pain; Vomiting

  MAUDE report 22024839 ↗
• InjuryMay 15, 2025Corroded; Biocompatibility; Corroded; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A BILATERAL METAL-ON-METAL R3 THA PERFORMED ON (B)(6) 2010, THE PATIENT PRESENTED IN (B)(6) 2024 WITH INCREASED LEFT AND RIGHT HIP PAIN, AS WELL AS MECHANICAL SYMPTOMS, AND ELEVATED COBALT/CHROMIUM ION LEVELS. MRI SHOWS EVIDENCE OF ARMD/ALTR, MORE PRONOUNCED ON THE LEFT. A REVISION SURGERY FOR THE LEFT HIP WAS PERFORMED ON (B)(6) 2024 DUE TO A FAILED LEFT TOTAL HIP ARTHROPLASTY WITH EVIDENCE OF ADVERSE REACTION TO METAL DEBRIS. A SMALL AMOUNT OF INFLAMMATORY FLUID WAS FOUND, BUT NO SIGNS OF INFECTION. NUMEROUS SAMPLES WERE SENT FOR CULTURE AND ALSO FOR PATHOLOGIC ANALYSIS TO EVALUATE FOR ADVERSE REACTION TO METAL DEBRIS. ABDUCTORS WERE INTACT AND NO EVIDENCE OF BONE LOSS. THE 48 MM HEAD AND METALLIC SLEEVE WERE REMOVED. IN THE FEMORAL HEAD THERE WAS A SIGNIFICANT AMOUNT OF INFLAMMATORY TISSUE WITHIN THE BASE, WITH SIGNIFICANT BLACK METALLIC STAINING, INDICATING SIGNIFICANT CORROSION PRODUCT. WITHIN THE BASE OF THE SLEEVE, THERE WAS ALSO SIGNIFICANT AMOUNT OF CORROSION PRODUCT. WHILE TRYING TO INSPECT THE STEM, A SMALL AMOUNT OF CORROSION PRODUCT WAS NOTICED ON THE TRUNNION. THE STEM WAS RETAINED AND CORROSION WAS CLEANED. THE LINE

  Patient problems: Cramp(s) /Muscle Spasm(s); High metal ion levels; Implant Pain; Inflammation; Metal Related Pathology; Pain

  MAUDE report 22023810 ↗
• InjuryDec 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A BILATERAL METAL ON METAL BHR THA PERFORMED ON (B)(6) 2010, A RIGHT REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO A BROKEN PROSTHESIS. IN THE SURGERY, A SIGNIFICANT AMOUNT OF ADVERSE LOCAL TISSUE REACTION WAS NOTED WITHIN THE CAPSULE. THE CAPSULE WAS NOTICED TO HAVE RELATIVELY THICKENED. THE FEMORAL HEAD WAS REMOVED. ACETABULUM, STEM AND SLEEVE APPEARED TO BE WELL FIXED IN APPROPRIATE ALIGNMENT, SO THEY WERE RETAINED. AN OR3O DM XLPE INSERT 28/48 AND AN OXINIUM FEM HD 12/14 28 MM 3 WERE IMPLANTED IN ORDER TO REPLACE THE REMOVED IMPLANT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 21047858 ↗
• InjuryDec 27, 2024Fracture; Biocompatibility; Fracture; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PATIENT UNDERWENT A BILATERAL METAL-ON-METAL BHR THA PERFORMED ON (6) (B)2010, SHE STARTED TO EXPERIENCE PAIN AROUND 2023 ALONG HER LEFT HIP. AN MRI DEMONSTRATED A SMALL LOCAL TISSUE REACTION AND A BROKEN INTERNAL LEFT HIP PROSTHESIS. IN ADDITION, A BLOOD TEST REVEALED AN ELEVATED COBALT-CHROMIUM LEVELS IN BLOOD. A REVISION SURGERY TO HER LEFT HIP WAS PERFORMED ON (B)(6) 2024, IN WHICH WAS NOTICED EVIDENCE OF OSTEOLYSIS IN THE INFERIOR ASPECT OF HER LEFT ACETABULUM. THERE WAS SOME SYNOVITIS NOTED AROUND THE CUP ACETABULAR COMPONENT, BUT THIS WAS NOTED TO BE WELL-FIXED. WITH SIGNIFICANT MANIPULATION THE LARGE FEMORAL HEAD WAS REMOVED FROM THE TRUNNION INTO 2 SEPARATE PIECES. INSIDE THE TRUNNION THERE WAS SOME BLACK DEBRIS CONSISTENT WITH TRUNNIONOSIS. A OXINIUM FEM HD 12/14 28MM -3 AND A OR3O DM XLPE INSERT 28/48 WERE IMPLANTED AND MADE AN EXCELLENT FIT AND MATCHING TO THE EXISTING CUP. ACETABULAR COMPONENT WAS WELL-POSITIONED AND DID NOT REQUIRE REVISION. THE HEAD AND SLEEVE WERE ALSO RETAINED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 21031273 ↗
• InjuryDec 5, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT BHR REVISION WAS PERFORMED ON (B)(6) 2010, PATIENT EXPERIENCED PAIN SINCE 2021 AND MECHANICAL FAILURES IN 2023. TESTS LATER REVEALED ELEVATED COBALT AND CHROMIUM LEVELS, OSTEOLYSIS AROUND THE GREATER TROCHANTER, AND THEY WERE DIAGNOSED WITH ADVERSE LOCAL TISSUE REACTION. THEREFORE, THEY UNDERWENT A REVISION SURGERY ON (B)(6) 2024. DURING SURGERY, BLACK AND SYNOVITIS BOTH THROUGHOUT THE CUP AND AROUND THE ACETABULUM WAS FOUND AND SUBSEQUENTLY DEBRIDED. ALL BHR COMPONENTS WERE EXCHANGED FOR A STRYKER SHELL AND BIOLOX CERAMIC HEAD. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE PACU IN STABLE CONDITION.

  Patient problems: Memory Loss/Impairment; Metal Related Pathology; Pain; Peripheral Nervous Injury

  MAUDE report 20854551 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THA SURGERY WAS PERFORMED IN AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION. TO ADDRESS THIS ADVERSE EVENT, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024, DURING WHICH A HEMI HEAD 46MM WAS REMOVED AND REPLACED WITH A TANDEM UNIPOLAR 46MM, WHILE RETAINING THE SHELL, R3 LINER AND STEM. IT WAS MENTIONED THAT THE PATIENT WAS IN BAD SHAPE FOR UNSPECIFIED REASONS. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20262832 ↗
• InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A R3-THA WAS PERFORMED ON (B)(6) 2010, THE PATIENT BENT FORWARD AND EXPERIENCED DISLOCATION OF THEIR HIP, THEY HAD TO ATTEND THE EMERGENCY ROOM ON (B)(6) 2023, AND WERE TREATED VIA A MANUEL REDUCTION. PATIENT WAS DISCHARGED IN STABLE CONDITION. FURTHER COMPLICATIONS RELATED TO THIS EVENT WERE NOT REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19459832 ↗
• InjuryMay 28, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT BHR-THA ON (B)(6) 2008 DUE TO DEGENERATIVE OSTEOARTHRITIS, THE PATIENT EXPERIENCED METALLOSIS ALONG WITH FEMORAL NECK OSTEOLYSIS. THIS EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE MODULAR HEAD AND SLEEVE WERE REMOVED. A 28MM OXINIUM FEMORAL HEAD AND A 28MMX46MM DUAL MOBILITY BEARING WERE PLACED IN EXCHANGE. EVEN THOUGH THERE WAS EVIDENCE OF OSTEOLYSIS ALONG THE ANTERIOR MARGIN OF THE ACETABULUM, THE CUP WAS RETAINED. THIS AREA WAS DEBRIDED WITHOUT COMPROMISING IMPLANT FIXATION AND THE ANTERIOR ACETABULAR WALL WAS BONE-GRAFTED. PATIENT WAS LATER TRANSFERRED TO THE PACU IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 19406429 ↗
• InjuryMay 23, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT BHR-THA ON (B)(6) 2008, THE PATIENT LATER EXPERIENCED SEVERE PAIN, LIMITING ADLS AND SLEEP, AND WERE DIAGNOSED WITH METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO CONVERT INTO A BIRMINGHAM DUAL MOBILITY HIP. A ONE DAY POST-OP VISIT REVEALED THE PATIENT SCAR HAD NO ERYTHEMA OR SWELLING, THE PATIENT HAD A NORMAL GAIT AND NO PAIN REPRODUCED WITH GENTLE IR/ER, FLEXION OR EXTENSION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19382357 ↗

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