BIOMET HIP SYSTEM 163668Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304256637), received between Mar 11, 2019 and May 9, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

13 other recalls cover devices cleared under the same FDA submission (K911684, K942479, K953925, K974558); 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.

• InjuryMay 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 16895697 ↗
• InjuryDec 28, 2021Material Erosion; Material Erosion

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Dizziness; Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 13098336 ↗
• InjurySep 28, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY AND SUBSEQUENTLY 5 YEARS LATER IS EXPERIENCING PAIN, LOSS OF BALANCE, DIZZINESS, ELEVATED METAL IONS, DIFFICULTY IN WALKING AND UPSET STOMACH DUE TO THE DETERIORATION AND FAILURE OF IMPLANT. NO REVISION HAS BEEN REPORTED AT THIS TIME. NO ADDITIONAL INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Dizziness; Metal Related Pathology; Nausea; Pain

  MAUDE report 12543510 ↗
• InjuryAug 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED MULTIPLE RECURRENT DISLOCATIONS/SUBLUXATIONS. THE PATIENT WAS TREATED WITH REPOSITION/REDUCTION UNDER SEDATION. THE PATIENT WAS LATER REVISED APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO THE MULTIPLE REOCCURRING DISLOCATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain; Subluxation

  MAUDE report 8908217 ↗
• InjuryMar 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 8408382 ↗
• InjuryMar 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 8407601 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K911684, K942479, K953925, K974558. One submission often covers many models, so check the product and lot details in each record.

• Z-1537-2018 · Apr 2, 2018 · Terminated
  Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need tot
• Z-0650-2016 · Nov 17, 2015 · Terminated
  Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
• Z-1757-2015 · Apr 16, 2015 · Terminated
  Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD
• Z-1286-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251
• Z-1285-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245
• Z-1288-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253
• Z-1289-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254
• Z-1282-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242
• Z-1287-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 2 straight stem; part 164252
• Z-1290-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 5 straight stem; part 164255
• Z-1281-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241
• Z-1283-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243
• Z-1284-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244