BIRMINGHAMHIPRESURFACING(BHR) 999904Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010504609), received between Jul 28, 2020 and Jun 16, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2022Break; Break

  IT WAS REPORTED THAT, DURING A BHR SURGERY, A BHR VENTING CANNULA 2.3MM BROKE WHEN TRYING TO PULL IT OUT OF THE FEMUR. THE SURGEON WAS ABLE TO PULL THE REST OF THE CANNULA OUT WITH THE RONGUER. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14719984 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT, WAS FOUND THE TIP OF THE VENTING CANNULA 2.3MM BROKE OFF. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367300 ↗
• MalfunctionJan 25, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF A BHR VENTING CANNULA 2.3MM IS BROKEN OFF. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353119 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED THAT A BHR VENTING CANNULA 2.3MM WAS FOUND TO BE BROKEN. AS THIS HAPPENED DURING A FIELD INSPECTION, THERE IS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336449 ↗
• MalfunctionJan 23, 2021Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE DEVICE WAS FOUND WITH A CHUNK TAKEN OUT AND BENT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11220169 ↗
• InjuryJul 28, 2020Contamination; Contamination

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE GOT CEMENT STUCK INSIDE. A CHANGE OF SURGICAL TECHNIQUE HAD TO BE PERFORMED TO FINISH THE SURGERY. THERE WAS NO DELAY NOR INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10331797 ↗

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-0033-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. 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-0018-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. 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-0023-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. 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-0020-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component.

…and 14 more.