BIOMET HIP SYSTEM 163660Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304256507), received between Nov 27, 2018 and Feb 10, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY SEVEN YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. THE HEAD WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 21345379 ↗
• InjuryMay 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION. DURING THE REVISION DUE TO PAIN AND LOOSENING, IT WAS DISCOVERED THAT THERE WAS INFECTION. INFECTION DETERMINED TO BE THE CAUSE OF OTHER ISSUES. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 14277498 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13860759 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION FOR UNKNOWN REASONS. NO FURTHER INFORMATION MADE AVAILABLE.

  Patient problems: Insufficient Information; No Information

  MAUDE report 8107317 ↗

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-1289-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254
• Z-1283-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243
• Z-1287-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 2 straight stem; part 164252
• Z-1284-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244
• 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-1281-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241
• Z-1290-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 5 straight stem; part 164255
• Z-1282-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242