BIOMET HIP SYSTEM 11-363661Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304210516), received between Apr 1, 2025 and Apr 1, 2025 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K032396); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 10 YEARS POST IMPLANTATION, THE PATIENT EXPERIENCED LEFT LATERAL PAIN CONSISTENT WITH TROCHANTER BURSITIS. PATIENT TOOK OVER THE COUNTER MEDICATION (NSAIDS) AND OUTPATIENT THERAPY WERE ADMINISTERED AND THE IMPLANTS REMAIN IMPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bursitis; Pain

  MAUDE report 21737992 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032396. One submission often covers many models, so check the product and lot details in each record.

• Z-1538-2018 · Apr 2, 2018 · Terminated
  Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatm
• Z-1008-2018 · Sep 15, 2017 · Terminated
  36MM COCR MODULAR HD -6MM
• Z-1860-2017 · Feb 17, 2017 · Terminated
  various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constr