Biomet® Hip System 163660Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868308253), received between Feb 14, 2022 and Jan 12, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• InjuryJan 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A CLOSED REDUCTION DUE HIP DISLOCATION. THE PATIENT SUFFERED TWO PREVIOUS DISLOCATIONS AND THE LATEST OCCURRED WHEN THEY WERE LYING IN BED AND TURNED ONTO THEIR HIP. THE HIP WAS REDUCED UNDER GENERAL ANESTHESIA WITHOUT DIFFICULTY. FOLLOWING THE PROCEDURE, WHEN PERFORMING TRACTIONS, THERE WAS SOME SUBLUXATION, SO THE HIP WAS IMMOBILIZED TO NOT FLEX THE HIP. THE FOLLOWING DAY, IT WAS RE-EVALUATED AND THE THIGH WAS LIFTED WITHOUT PROBLEM OR PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 24032912 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON DUE TO INFECTION. THE LINER, BEARING, AND HEAD WERE EXCHANGED. THE STEM AND SHELL REMAIN IMPLANTED. NO OPERATIVE RECORDS PROVIDED. UPON RECEIPT OF THE STERILE CERT FOR THIS DEVICE, IT WAS DETERMINED THAT THIS PRODUCT WAS NOT A CONTRIBUTING FACTOR OF THE REPORTED EVENT AND THIS REPORT CAN THEREFORE BE VOIDED.

  Patient problems: Medical device site infection

  MAUDE report 23497615 ↗
• InjuryOct 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS LATER DUE TO RECURRENT DISLOCATIONS. DUE TO THE DEGRADATION OF THE BONE AND SOFT TISSUE IN THE HIP, THE SURGEON DETERMINED THAT THE HIP WAS NO LONGER STABLE AND WOULD KEEP DISLOCATING. THEREFORE, ALL COMPONENTS WERE REMOVED, AND THE HIP WAS FUSED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Dislocation; Muscle/Tendon Damage

  MAUDE report 20517420 ↗
• InjuryFeb 14, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 13523048 ↗