Biomet® Hip System 163638Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887868308215), received between Mar 29, 2022 and Oct 29, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated4
- Detachment of Device or Device Component1
Patient problems
- Joint Dislocation5
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISSOCIATION OF THE HEAD AND BEARING FOLLOWING A FALL. A NEW LINER, BEARING, HEAD, AND TAPER SLEEVE WERE IMPLANTED. IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 23418182 ↗InjuryOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 23310482 ↗InjuryDec 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 21048608 ↗InjuryNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 18181763 ↗InjuryMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY THA (DUALMOBILITY) PERFORMED DUE TO OSTEOARTHROSIS AND PAIN WHEN WEIGHT WAS PLACED ON THE IMPLANT SIDE. SUBSEQUENTLY THE IMPLANTS WAS REVISED DUE TO THE INNER HEAD WAS DISLOCATED FROM THE OUTER BEARING OF THE DM APPROXIMATELY EIGHT MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Pain
MAUDE report 13942984 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.