BIRMINGHAM HIP RESURFACING (BHR) 74122146Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010565792), received between Feb 20, 2019 and Jun 12, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Biocompatibility” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY BHR RIGHT HIP SURGERY ON (B)(6) 2007 AND SUBSEQUENTLY SUFFERED FROM FAILED METAL ON METAL. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2015 TO EXCHANGE ACETABULAR CUP HAP SIZE 40/46 AND FEMORAL HEAD 40MM. FURTHERMORE, IT WAS DONE ACETABULAR RECONSTRUCTION USING EXTENSIVE BONE GRAFTING, BOTH PATIENT'S OWN BONE AND ALLOGRAFT FEMORAL HEAD REAMINGS, AND EXCISION OF PSEUDO-TUMOR GRANULOMA. ALSO, EXCISED THE CAPSULE AND THE PSEUDOCAPSULE FROM AROUND THE JOINT IN ITS ENTIRETY. HER WOUND WAS WASHED AND DRIED, COVERED WITH STERILE PRESSURE DRESSING. PATIENT WAS TRANSFERRED OFF THE TABLE ON TO A STRETCHER. SHE TOLERATED THE PROCEDURE WELL.

  Patient problems: Cyst(s); Deformity/ Disfigurement; Metal Related Pathology

  MAUDE report 19520327 ↗
• InjuryMay 23, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2009 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED OSTEOLYSIS, BUTTOCK PAIN AND ELEVATED METAL LEVELS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, IN WHICH JOINT FLUID, SYNOVIAL HYPERTROPHY AND OSTEOLYSIS OF THE FEMORAL NECK WERE FOUND. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 14467747 ↗
• InjuryMay 31, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2012 DUE TO OSTEOARTHRITIS OF THE RIGHT HIP, THE PLAINTIFF EXPERIENCED FAILED HIP RESURFACING DEVICE, ADVERSE LOCAL TISSUE REACTION, TISSUE DAMAGE, PERIPROSTHETIC LUCENCY IN THE FEMORAL NECK AND A THIN (1-2 MM) RIM OF REMAINING INTACT CORTEX, METALLOSIS, ELEVATED ION LEVELS, PAIN, INFLAMMATION, AND DIFFICULTY WALKING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. ACETABULAR COMPONENT WAS WELL FIXED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Inflammation; Loss of Range of Motion; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 11910750 ↗
• 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 DUE TO ELEVATED COBALT AND CHROMIUM LEVELS PLUS PAIN ON THE RIGHT SIDE FOLLOWING PRIMARY SURGERY.

  Patient problems: Arthralgia; High metal ion levels; Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 11376137 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BILATERAL PATIENT. PLAINTIFF UNDERWENT MEDICALLY-INDICATED TWO-STAGE REVISION OF THE BHR-THA LEFT HIP IMPLANTS ON (B)(6) 2018. (1ST STAGE) AND (B)(6) 2019 (2ND STAGE). IN THE FIRST STAGE, THE STEM WAS REMOVED AND REPLACE WITH A ZIMMER ONE. A FUNCTIONAL ANTIBIOTIC SPACER WAS ALSO PLACED. IN THE SECOND STAGE, THE ZIMMER STEM WAS REMOVED AGAIN ALONG WITH THE BHR-THA SHELL, HEAD AND SLEEVE. THE PATIENT¿S TWO (2) STAGE REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED BACILLUS HIP INFECTION, ELEVATED METAL ION LEVELS AND METALLOSIS WITH ADVERSE LOCAL TISSUE REACTION, SEVERE PAIN, LIMITED MOBILITY, AND PSEUDOTUMOR FORMATION. NO S&N PARTS REMAINED IMPLANTED.

  Patient problems: Bacterial Infection; Failure of Implant; Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 10908773 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CAN LEGAL IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENTS LEFT HIP DUE TO METALLOSIS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Laxity; Metal Related Pathology; No Code Available; Test Result

  MAUDE report 10173274 ↗
• InjuryFeb 20, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY FROM THE LEFT HIP WAS PERFORMED DUE TO PAIN, DISCOMFORT AND ELEVATED CHROMIUM LEVELS.

  Patient problems: Discomfort; Pain; Toxicity

  MAUDE report 8353792 ↗

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-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. 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-0023-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. 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-0030-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. 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-0031-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. 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.