Biomet® Hip System 163669Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Biomet Hip System (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887868308338), received between Oct 31, 2022 and Jul 10, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated5
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation5
- Subluxation2
- Fall1
- Osteopenia/ Osteoporosis1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR A SECOND TIME APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO DISLOCATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 22469189 ↗InjuryDec 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. THE HEAD AND LINER WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 21045022 ↗InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY SIXTEEN MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO REPORTED FAILURE OF ANY IMPLANTS, BUT THE SURGEON NOTED POSSIBLE MALPOSITION OF THE SHELL AS CONTRIBUTING. THE SHELL, LINER, AND HEAD WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Osteopenia/ Osteoporosis; Pain
MAUDE report 19228857 ↗InjuryMar 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS AND HAD A REVISION SURGERY DUE TO IMPLANT WEAR. SUBSEQUENTLY, THE PATIENT WAS REVISED A SECOND TIME DUE TO DISLOCATION. THE HEAD AND LINER WERE EXCHANGED.
Patient problems: Joint Dislocation
MAUDE report 18817315 ↗InjuryJan 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY THE PATIENT EXPERIENCED DISLOCATION AND SUBLUXATION RESULTING IN CLOSED REPOSITIONING. NO FURTHER COMPILATIONS HAVE BEEN REPORTED AND THE PATIENT REMAINS VERY SATISFIED WITH HIS NEW JOINT AT THIS TIME. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Fall; Joint Dislocation; Subluxation
MAUDE report 16112605 ↗InjuryOct 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT EXPERIENCED A SUBLUXATION WITH NON-SURGICAL REPOSITIONING APPROXIMATELY 12 DAYS POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT EXPERIENCED A SECOND SUBLUXATION WITH A LIFTING TASK APPROXIMATELY 6 YEARS LATER AND A THIRD SUBLUXATION APPROXIMATELY 8 MONTHS LATER. NON-SURGICAL REPOSITIONING WAS PERFORMED AFTER BOTH EPISODES OF SUBLUXATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation; Subluxation
MAUDE report 15704243 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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