Biomet® Hip System 11-363660Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868307935), received between Feb 2, 2022 and Nov 18, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 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.

• InjuryNov 18, 2025Material Erosion; Material Erosion

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Bursitis; High metal ion levels; Joint effusion; Metal Related Pathology; Muscle/Tendon Damage; Pain; Unequal Limb Length

  MAUDE report 23581757 ↗
• InjuryAug 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 20030661 ↗
• InjuryApr 16, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED AT A PATIENT UNDERWENT A HIP PROCEDURE APPROXIMATELY SIX DAYS POST IMPLANTATION TO IMPLANT THE CORRECT SIZE. THE HEAD WAS REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19116547 ↗
• InjuryFeb 2, 2022Off-Label Use; Unintended Movement; Off-Label Use; Unintended Movement

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, ACETABULAR COMPONENT LOOSENING, AND SOFT TISSUE IMPINGEMENT CAUSED BY INCOMPATIBLE HEAD AND LINER COMPONENT IMPLANTATION. THE CUP. LINER AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 13423902 ↗

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