Biomet® Hip System 11-363663 (UDI 00887868307966)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868307966), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 death.

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

• DeathJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO WEEKS POST THE INITIAL PROCEDURE BECAUSE A PROPER FIT WAS NOT ABLE TO BE OBTAIN BETWEEN THE LINER AND THE SHELL DURING THE INITIAL PROCEDURE. THERE WAS THIS DELAY BETWEEN THE TWO PROCEDURES DUE TO NEEDING TO OBTAIN COMPATIBLE BLOOD PRODUCTS FOR THE PATIENT. THE SURGERY ITSELF WAS ALSO PROLONGED DUE TO NUMEROUS COMPLICATIONS INCLUDING EXCESSIVE BLEEDING, INCORRECT COMPONENT POSITIONING, FEMUR FRACTURE, AND ADDITIONAL DIFFICULTY WITH IMPLANT PLACEMENT. ULTIMATELY, SATISFACTORY IMPLANTATION WAS ACHIEVED AND THE PROCEDURE CONCLUDED. HOWEVER, THE PATIENT IS REPORTED TO HAVE EXPIRED WITHIN 4 HOURS AFTER THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17408643 ↗

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