BIOMET HIP SYSTEM 11-363665Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304210554), received between Nov 2, 2021 and Apr 4, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Erosion” (2 reports).

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

• InjuryApr 4, 2024Material Erosion; Material Erosion

  ADDITIONAL INFORMATION RECEIVED THAT APPROXIMATELY 5 MONTHS PRIOR TO THE PATIENT¿S REVISION, 20ML WAS ASPIRATED FROM THE RIGHT GREATER TROCHANTERIC AREA DUE TO PAIN. NUMBING MEDICATION WAS INJECTED WITHOUT STEROIDS. THE PAIN WAS MINIMALLY RESOLVED WITH INJECTION; HOWEVER, THE PAIN RETURNED. THE PATIENT REMAINED ON CHRONIC PREDNISONE THERAPY. A SECOND INJECTION WAS PLANNED PRIOR TO THE REVISION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: High metal ion levels; Joint effusion; Metal Related Pathology; Pain

  MAUDE report 19047130 ↗
• InjuryJan 9, 2024Corroded; Corroded

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18479022 ↗
• InjuryFeb 28, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO FRACTURE OF THE POLY LINER AFTER A DISLOCATION EVENT CAUSING THE HIP TO BECOME UNSTABLE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 13618188 ↗
• InjuryNov 2, 2021Material Erosion; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Material Erosion; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Metal Related Pathology; Necrosis; Pain; Swelling/ Edema

  MAUDE report 12738774 ↗

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