Biomet® Hip System 11-363661Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868307942), received between Feb 14, 2022 and Feb 11, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 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.

• InjuryFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A DISLOCATION. THE DISLOCATION WAS REPORTEDLY DUE TO THE FALL; HOWEVER, THERE WAS NO INFORMATION RELATED TO HOW THE PATIENT FELL OR THE CAUSE OF THE FALL. A SUCCESSFUL HEAD AND LINER EXCHANGE WAS PERFORMED ON THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 21357146 ↗
• InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 3 YEARS LATER DUE TO PAIN AND DIFFICULTY AMBULATING FROM POLY LINER WEAR AND DISLOCATION. THE HEAD AND LINER WERE REPLACED WHILE THE STEM AND CUP REMAIN INTACT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation; Pain

  MAUDE report 21255775 ↗
• InjuryNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FIVE MONTHS POST IMPLANTATION DUE TO DISLOCATION FOLLOWING AN INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 18048281 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A MOTOR VEHICLE ACCIDENT RESULTING IN MULTIPLE FRACTURES AND A LEFT HIP OPEN REDUCTION INTERNAL FIXATION APPROXIMATELY 21 YEARS AGO. OVER TIME, THE PATIENT DEVELOPED POSTTRAUMATIC AVASCULAR NECROSIS OF THE HIP AND UNDERWENT A STAGED PROCEDURE WITH HARDWARE REMOVAL AND ANTIBIOTIC CEMENT BEAD PLACEMENT IN STAGE ONE THEN AND A LEFT TOTAL HIP ARTHROPLASTY ONE WEEK LATER. DURING THE INITIAL PROCEDURE, THE FEMUR WAS BROACHED TO ACCEPT A 15, BUT UPON PLACING THE FINAL IMPLANT, DID NOT QUITE MAKE IT ALL THE WAY DOWN. THE SURGEON WAS SATISFIED WITH THE RESULT AND CLOSED THE PATIENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS LEFT WITH A HALF INCH LEG LENGTH DISCREPANCY AND REPORTED ONGOING PAIN AND DIFFICULTIES. PHYSICAL THERAPY HAS BEEN EXHAUSTED AND DISCONTINUED TO LACK OF PROGRESS, PHYSICAL DECONDITIONING, AND INJURY PREVENTION DUE TO PATIENT EXPECTATIONS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unequal Limb Length

  MAUDE report 13523094 ↗

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