BIRMINGHAM HIP RESURFACING (BHR) 74122152Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010552280), received between May 3, 2018 and Jun 28, 2022 — classified as 13 injuries.

The most frequently reported specific device problem is “Biocompatibility” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2022Biocompatibility; Biocompatibility

  BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A BILATERAL BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT AND RIGHT HIP ON (B)(6) 2009 RESPECTIVELY, THE PATIENT REQUIRED A REVISION ARTHROPLASTY OF THE RIGHT HIP IMPLANTS ON (B)(6) 2022. AMONG THE REPORTED SYMPTOMS THAT MADE NECESSARY THIS INTERVENTION, THE PATIENT EXPERIENCED ELEVATED COBALT LEVELS IN BLOOD REFERRED AS TO BE ¿IN THE UPPER 40S¿. ALTHOUGH THERE IS NO EVIDENCE OF ANY INTERVENTION PERFORMED ON THE LEFT BHR RESURFACING IMPLANTS, THE CONTRIBUTION OF THIS PROSTHESIS TO THE REPORTED COBALT LEVELS COULD NOT BE DISCARDED.

  Patient problems: Metal Related Pathology

  MAUDE report 14844848 ↗
• InjuryMay 26, 2022Biocompatibility; Biocompatibility

  US LEGAL. IT WAS REPORTED THAT, AFTER A PRIMARY RIGHT BHR SURGERY WAS PERFORMED ON (B)(6) 2009 DUE TO DEGENERATIVE ARTHRITIS WITH MILD DYSPLASIA; THE PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2021. THE REVISION SURGERY WAS INDICATED DUE TO FAILED RIGHT BHR SECONDARY, ADVERSE LOCAL TISSUE REACTION/METALLOSIS AND ELEVATED SERUM COBALT/CHROMIUM ION LEVELS. THE STATUS OF THE PLAINTIFF IS UNKNOWN.

  Patient problems: Metal Related Pathology; Swelling/ Edema

  MAUDE report 14504088 ↗
• InjuryMar 24, 2022Biocompatibility; Biocompatibility

  US LEGAL: BILATERAL PATIENT. IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2012, THE PATIENT UNDERWENT ANOTHER REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2021 DUE TO MECHANICAL COMPLICATION OF PROSTHETIC HIP IMPLANT, OSTEOLYSIS, METALLOSIS AND PERIPROSTHETIC FRACTURE. THE PRIMARY LEFT BHR WAS PERFORMED ON (B)(6) 2009. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Hip Fracture; Metal Related Pathology; Osteolysis

  MAUDE report 13896919 ↗
• InjuryDec 27, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT BHR SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED ELEVATED CHROMIUM AND COBALT LEVELS. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2018 TO TREAT THIS ADVERSE EVENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 13087700 ↗
• InjurySep 28, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BHR SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT PRESENTED AN UNSPECIFIED CONDITION THAT REQUIRED A REVISION SURGERY ON (B)(6)2021. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Insufficient Information; Metal Related Pathology; Pain

  MAUDE report 12540361 ↗
• InjuryJun 24, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR PRIMARY SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HIP PAIN AND RAISED METAL LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE FEMORAL HEAD 44MM ((B)(4)) AND ACETABULAR CUP HAP SIZE 44/52 ((B)(4)) WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 12059532 ↗
• InjuryMar 12, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA PATIENT UNDERWENT A REVISION SURGERY ON 01/02/2021 DUE TO METALLOSIS. CUP AND HEAD WERE EXPLANTED AND AN EXTENSIVE WASHING WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 11476321 ↗
• InjuryJul 11, 2020Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENTS LEFT HIP DUE TO SEVERELY ELEVATED COBALT AND CHROMIUM LEVELS, AND GRAY-STAINED SYNOVIUM DUE TO METALLOSIS AS A RESULT OF THE PREMATURE FAILURE OF THE DEVICE.

  Patient problems: Injury; Metal Related Pathology

  MAUDE report 10261752 ↗
• InjuryNov 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ALTERATION OF CHROMIUM AND COBALT VALUES AND BONE REDUCTION.

  Patient problems: Injury; No Code Available

  MAUDE report 8060694 ↗
• InjuryNov 12, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO PAIN, ELEVATED METAL ION LEVELS AND PSEUDOTUMOUR.

  Patient problems: Pain; Swelling; Test Result; Toxicity

  MAUDE report 8059016 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF THE RIGHT HIP WAS PERFORMED DUE TO: PAIN, ELEVATED COBALT AND CHROMIUM, AND METALLOSIS.

  Patient problems: Pain; Test Result; Toxicity

  MAUDE report 8020606 ↗
• InjuryAug 31, 2018Insufficient Device Problem Information; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED. METALLOSIS AND ASEPTIC LYMPHOCYTE-DOMINANT VASCULITIS-ASSOCIATED LESION (AVAL) REPORTED.

  Patient problems: Swelling; Test Result; Tissue Damage; Toxicity

  MAUDE report 7836414 ↗
• InjuryMay 3, 2018Appropriate Device Problem Term/Code Not Available

  BILATERAL PATIENT. IT WAS REPORTED THAT LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS, ELEVATED METAL ION LEVELS IN BLOOD AND PSEUDOTUMOR FORMATION . FLUID IN JOINT, FOREIGN BODY REACTION NOTED DURING REVISION.

  Patient problems: Foreign Body Reaction; Toxicity

  MAUDE report 7482330 ↗

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-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-0033-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. 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-0026-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. 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-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.
• Z-0028-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. 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.

…and 14 more.