BIRMINGHAM HIP 90128257Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010533791), received between Jul 12, 2020 and Mar 31, 2026 — classified as 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A BIRMINGHAM HIP RESURFACING SURGERY, WHILE IMPACTING THE METAL PIECE OF ONE (1) BHR CURVED CUP INTRODUCER, USE TO HOLD AN ALIGNMENT TOWER, THE PIECE DISLODGED AND FLEW OFF THE DEVICE. THIS PIECE IS NOT REMOVAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750419 ↗
• MalfunctionMar 9, 2026Fracture

  IT WAS REPORTED THAT DURING A BHR HIP RESURFACING SURGERY, THE WIRE ATTACHMENT OF ONE (1) BHR CURVED CUP INTRODUCER BROKE OFF AS CUP WAS BEING IMPACTED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542283 ↗
• MalfunctionAug 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY THE TIP OF ONE (1) BHR CURVED CUP INTRODUCER BROKE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804819 ↗
• MalfunctionApr 11, 2025Fracture; Solder Joint Fracture; Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) BHR CURVED CUP INTRODUCER BROKE DURING USE. A WELD BROKE LOOSE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827934 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT, DURING BHR SURGERY, A BHR CURVED CUP INTRODUCER BROKE DURING IMPACTION OF CUP. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THIS EVENT CAUSED AN INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783886 ↗
• MalfunctionMay 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE BOLT OF A BHR CURVED CUP INTRODUCER FRACTURED DURING IMPACTION. NOTHING FELL INTO THE WOUND. THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY. NO BACK-UP DEVICE NEEDED AS THE PART BROKE UPON FINAL MALLET HIT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313186 ↗
• MalfunctionAug 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A BHR PROCEDURE, THE ATTACHMENT FOR THE CROSSBAR OF THE BHR CURVED CUP INTRODUCER BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440563 ↗
• MalfunctionMar 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING A BHR SURGERY, THE TIP OF A BHR CURVED CUP INTRODUCER BROKE WHILE IMPACTING. THE PROCEDURE WAS RESUMED, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN IF A DELAY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527361 ↗
• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED THAT, DURING A THR, THE CENTRAL THREAD OF ONE (1) BHR CURVED CUP INTRODUCER SNAPPED UPON IMPACTION. THERE WAS NO DELAY AND PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372806 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY THE BHR CURVED CUP INTRODUCER BROKE WHILE BEING HIT WITH MALLET. THE DEVICE BROKE WHILE BEING USED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252338 ↗
• InjuryJan 11, 2022Break; Break

  IT WAS REPORTED THAT WHILE IMPACTING THE ACETABULAR COMPONENT DURING A THR, THE BHR CURVED CUP INTRODUCER BROKE AND WOULD NO LONGER STAY ATTACHED TO THE IMPLANT (INSIDE THE PATIENT). A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226071 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE BRACKET THAT HOLDS THE X-BAR TO THE BHR CURVED CUP INTRODUCER BROKE OFF WHILE THE INSTRUMENT WAS MANIPULATED OUTSIDE THE PATIENT. NO SURGICAL DELAY WAS REPORTED TO OCCUR AS A CONSEQUENCE OF THIS MALFUNCTION, AND THE PROCEDURE WAS CONCLUDED WITH THE SAME DEVICE. NO PATIENT HARM WAS REPORTED TO OCCUR DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177042 ↗
• MalfunctionOct 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE BHR CURVED CUP INTRODUCER BROKE. SURGERY/TREATMENT WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12582908 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR A THR, THE BHR CURVED CUP INTRODUCER WAS MISSING THE NON THREADED PEG ON THE BOTTOM, IT LOOKED AS THE PEG WAS BROKEN OFF. NO SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579165 ↗
• InjuryOct 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INTERNAL WIRE TENSIONER OF A BHR CURVED CUP INTRODUCER BROKE OFF UPON IMPACTION OF THE ACETABULAR CUP. NO SURGICAL DELAY WAS REPORTED TO OCCUR DUE TO THIS INCIDENT, AND THE PROCEDURE WAS CONCLUDED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT HARM WAS REPORTED TO OCCUR AS A CONSEQUENCE OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561081 ↗
• MalfunctionSep 16, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A THR SURGERY, A BHR CURVED CUP INTRODUCER WAS FOUND TO BE BROKEN. NO SURGICAL DELAY REPORTED, AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484773 ↗
• InjuryJul 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE BHR CURVED CUP INTRODUCER BROKE INTERNAL TO PATIENT. THE PIECE THAT THE ALIGNMENT GUIDE ATTACHES TO BROKE OFF WHILE POUNDING TO THE BHR CUP IN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103014 ↗
• MalfunctionJun 9, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, FOR A BHR CURVED CUP INTRODUCER, THE HANDLE NO LONGER TIGHTENS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. VISUAL INSPECTION WAS CARRIED OUT ON THE INSTRUMENT. THERE ARE MARKS AND SCRATCHES ACROSS THE WHOLE LENGTH OF THE INSTRUMENT CONSISTENT WITH SURGICAL USE. WELDS ARE FREE OF PITS CROCKS AND VOIDS. THERE IS HEAVY IMPACT DAMAGE TO THE HEAD OF THE IMPACTOR. THE THREADS ARE DAMAGED AND DEFORMED. THERE IS A BREAK IN THE MIDDLE SCREW THREAD. PART IS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963596 ↗
• MalfunctionMar 10, 2021Break; Break

  IT WAS REPORTED THAT, FOR A BHR CURVED CUP INTRODUCER, THE WELD BELOW THE IMPACTING SURFACE WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11452155 ↗
• MalfunctionFeb 14, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION, THE WELDING BROKE AROUND THE END OF THE IMPACTOR FOR A BHR CURVED CUP INTRODUCER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326264 ↗
• MalfunctionDec 31, 2020Break; Break

  IT WAS REPORTED THAT THE ITEM WAS FOUND BROKEN. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11100527 ↗
• MalfunctionDec 24, 2020Break; Break

  IT WAS REPORTED THAT THE ALIGNMENT GUIDE HOLDER BROKE. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072446 ↗
• MalfunctionOct 13, 2020Break; Break

  IT WAS REPORTED THAT A PIECE OF THE INTRODUCER BROKE AS THE CUP WAS BEING PUT ON. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. A S&N BACKUP WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10671342 ↗
• MalfunctionSep 28, 2020Crack

  IT WAS REPORTED THAT UPON INSPECTION THE DEVICE WAS FOUND WITH A CRACKED WELD. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10597867 ↗
• MalfunctionAug 13, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN DURING A ROUTINE EFIP INSPECTION. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10401216 ↗

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-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-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-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-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. 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-0019-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. 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-0033-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. 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-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component.

…and 14 more.