BIRMINGHAM HIP RESURFACING (BHR) 74120144Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010502537), received between Sep 13, 2018 and Oct 19, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENTS LEFT HIP DUE TO ELEVATED METAL ION LEVELS. THE PATIENT UNDERWENT LEFT HIP REPLACEMENT IN 2011 WITH BHR AND ADR COMPONENTS, AND RIGHT HIP REPLACEMENT WITH UNKNOWN DEVICES. THE PATIENT STARTED SUFFERING FROM METALLOSIS SYMPTOMS AND HAD TO UNDERGO 2 REVISIONS SURGERIES ON (B)(6) 2017 AND (B)(6) 2017 TO CORRECT THE ISSUE AND BEGIN REHABILITATION.

  Patient problems: Toxicity

  MAUDE report 10702531 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use 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 ELEVATED METAL ION LEVELS. THE PATIENT UNDERWENT LEFT HIP REPLACEMENT IN 2011 WITH BHR AND ADR COMPONENTS, AND RIGHT HIP REPLACEMENT WITH UNKNOWN DEVICES. THE PATIENT STARTED SUFFERING FROM METALLOSIS SYMPTOMS AND HAD TO UNDERGO 2 REVISIONS SURGERIES ON (B)(6) 2017 AND (B)(6) 2017 TO CORRECT THE ISSUE AND BEGIN REHABILITATION.

  Patient problems: Injury

  MAUDE report 10702504 ↗
• InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO BILATERAL HIP PAIN AND INCREASED COBALT AND CHROMIUM LEVELS ON BLOOD.

  Patient problems: Pain; Toxicity

  MAUDE report 9933172 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SCHEDULED BHR RIGHT HIP REVISION SURGERY WILL BE PERFORMED DUE TO PAIN, LIMITED MOBILITY, PSEUDOTUMOR AND ELEVATED METAL ION LEVELS..

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Toxicity

  MAUDE report 9877753 ↗
• InjuryMar 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY ON THE RIGHT HIP WAS PERFORMED DUE TO PAIN, FAILURE OF HARDWARE, ELEVATED LEVELS OF COBALT AND CHROMIUM, METAL TOXICITY, METALLOSIS, PSEUDOTUMORS, BONE AND TISSUE LOSS, AND LOSS OF MOBILITY. THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A BHR RESURFACING SYSTEM. THERE IS NO INFORMATION REGARDING TO THE DEVICES EXPLANTED ON THE REVISION SURGERY.

  Patient problems: Injury

  MAUDE report 9875606 ↗
• InjurySep 13, 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 METALLOSIS AND ELEVATED LEVELS OF COBALT AND CHROMIUM.

  Patient problems: Test Result; Toxicity

  MAUDE report 7873369 ↗

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-0031-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. 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-0023-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. 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-0018-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. 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-0029-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia 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.

…and 14 more.