BIOMET HIP SYSTEM 11-363660Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304210509), received between Apr 14, 2023 and May 1, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

1 FDA recall record name this device's identifier.

2 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.

Recalls naming this device

1. Sep 15, 2017Class IITerminated

   One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.

   Z-1008-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED SEVEN (7) YEARS POST IMPLANTATION DUE TO MALPOSITION OF THE CUP AND THE TRUNNION OF THE STEM SITTING INFERIOR OF THE CUP. THE HEAD, CUP, AND LINER WERE EXPLANTED. THE PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCTS. DILIGENCE FOR ADDITIONAL INFORMATION IS ONGOING.

  Patient problems: Crepitus; Failure of Implant

  MAUDE report 21943903 ↗
• InjuryApr 14, 2023Migration; Migration

  UPON REASSESSMENT OF THE REPORTED EVENT, THE HEAD 11-363660 WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT 0001825034 - 2023 - 00819 WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 16742088 ↗

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-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