BIOMET HIP SYSTEM 163661Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304256521), received between Sep 4, 2024 and Sep 4, 2024 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20138484 ↗

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-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-1284-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244
• Z-1282-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242
• Z-1285-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245
• Z-1281-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241
• Z-1288-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253
• Z-1286-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251
• Z-1283-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243
• Z-1289-03 · Jun 18, 2003 · Terminated
  Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254