BIRMINGHAM HIP RESURFACING (BHR) 74122162Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010552334), received between Jul 26, 2018 and Apr 13, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT BHR SURGERY WAS PERFORMED ON(B)(6)2011 DUE TO OSTEOARTHRITIS, SEVERE PAIN AND LIMITATION OF MOTION AND FUNCTION, THE PATIENT EXPERIENCED SYMPTOMS THAT RAISED SUSPICION OF ELEVATED COBALT LEVELS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6)2019 IN WHICH MINIMAL SYNOVITIS AROUND THE JOINT WAS OBSERVED. CURRENT PATIENT¿S HEALTH STATUS IS UNKNOWN.

  Patient problems: Infiltration into Tissue; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 14101559 ↗
• InjuryFeb 2, 2022Biocompatibility; Biocompatibility

  USA LEGAL. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2021 DUE TO TRUNNIONOSIS, INFLAMMATORY AND ADVERSE LOCAL SOFT TISSUE REACTION ASSOCIATED WITH METAL-ON-METAL BEARING OF HIP REPLACEMENT PROTHESIS AN RIGHT GREATER TROCHANTERIC DISPLACED FRACTURE (PATHOLOGIC TYPE-RELATED TO OSTEOLYSIS-). THE PRIMARY RIGHT BHR THA SURGERY WAS PERFORMED ON (B)(6) 2009. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

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

  MAUDE report 13423122 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO AN INFECTION. HEAD AND CUP WERE EXPLANTED AND AN ANTIBIOTIC CEMENT WAS PUT IN TO ADDRESS THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11023456 ↗
• InjuryNov 10, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING BHR SURGERY, WHILE IMPLANTED THE BHR ACETABULAR COMPONENT CAP/ IMPACTOR AND WIRE, THE SURGEON MOUNTED THE CUP ON THE SLIMLINE INTRODUCER. THE WIRE SNAPPED WITH THE FIRST HAMMER BLOW WHEN CUP WAS IMPLANTED. SURGEON HAD TO ADJUST HIS TECHNIQUE TO IMPLANT A HALF IMPLANTED COMPONENT DUE TO THIS ISSUE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10815906 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 ON A PATIENT HIP DUE TO AN INFECTION. THE PATIENT WAS OPENED UP TO MADE A WASH OUT, AND RE-CLOSED AGAIN. NO PARTS WERE EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 10597827 ↗
• InjuryJan 15, 2020Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A BHR REVISION WAS PERFORMED FOR UNKNOWN REASONS.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 9592107 ↗
• InjuryFeb 5, 2019Fracture; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE FEMORAL STEM AT THE NECK. ELEVATED METAL LEVELS IN HIS BLOOD WERE ALSO FOUND.

  Patient problems: Failure of Implant; Toxicity

  MAUDE report 8305372 ↗
• InjuryJul 26, 2018Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO A SOFT TISSUE REACTION.

  Patient problems: Reaction; Test Result

  MAUDE report 7721589 ↗

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-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-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-0018-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. 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-0028-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
• Z-0025-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. 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-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. 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-0033-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component.

…and 14 more.