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BIRMINGHAM HIP RESURFACING (BHR) 90127585Recalls & reported problems

Smith & Nephew, Inc. · 6.8MM GUIDE BAR · Class 3

All models of BIRMINGHAM HIP RESURFACING (BHR) (47)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010590190), received between Mar 19, 2021 and Oct 18, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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

Device problems

  • Material Twisted/Bent2
  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 18, 2021Break; Break

    IT WAS REPORTED THAT DURING A THR, A 6.8MM GUIDE BAR DISSEMBLED DURING REAMING. THE SHAFT OF THE GUIDE BAR WAS STUCK IN THE REAMER, AND THE SCREW WAS RECOVERED FROM THE INCISION BY HAND. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, NO DELAY REPORTED. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12647131 ↗
  • MalfunctionMar 25, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT, DURING A THR WAS NOTICED THE 6.8MM GUIDE BAR BENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11568136 ↗
  • MalfunctionMar 19, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT, A 6.8MM GUIDE BAR BENT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11526162 ↗

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-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-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-0025-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. 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-0032-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. 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-0020-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. 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-0031-2008 · Jul 12, 2007 · Terminated
    Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. 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.

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Sources and updates

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