Biomet® Hip System 163661Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Biomet Hip System (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887868308260), received between Aug 13, 2020 and Sep 15, 2026 — classified as 11 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated8
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component2
- Difficult to Insert1
Patient problems
- Joint Dislocation9
- Fall2
- Pain2
- Bone Fracture(s)1
- Failure of Implant1
- Medical device site infection1
- Nerve Damage1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Device Dislodged or Dislocated
It was reported that the patient underwent an initial hip procedure. Subsequently, the patient was revised due to dislocation approximately 12 weeks after. Attempts have been made and no further information has been provided.
Patient problems: Joint Dislocation
MAUDE report 50777887 ↗InjuryMay 21, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT ONE DAY POST HIP REVISION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION. THE PROXIMAL BODY AND DISTAL STEM WERE FOUND TO BE LOOSE AND NOT MATED PROPERLY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25244603 ↗InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND WAS SUBSEQUENTLY REVISED APPROXIMATELY 3 WEEKS POST-IMPLANTATION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Medical device site infection
MAUDE report 23406474 ↗InjuryOct 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Fall; Joint Dislocation
MAUDE report 20578029 ↗InjurySep 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION THAT WAS EXPERIENCED AFTER FALLING. ALL OF THE COMPONENTS WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 20310780 ↗InjurySep 18, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s); Failure of Implant; Joint Dislocation; Pain
MAUDE report 17764556 ↗InjuryAug 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 17493778 ↗MalfunctionJul 24, 2023Difficult to Insert; Difficult to Insert
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17381082 ↗InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Nerve Damage; Pain
MAUDE report 17010637 ↗InjuryMar 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A HIP PROCEDURE THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY TWO (2) WEEKS LATER. THE PATIENT WAS REVISED DUE TO DISLOCATION FROM FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Fall; Joint Dislocation
MAUDE report 16477597 ↗InjuryMar 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SURGEON CONTRIBUTES THE DISLOCATION TO THE PATIENT THRASHING AND MOVING AROUND IN THE MIDDLE OF THE NIGHT. THEREFORE, THERE WAS NO ALLEGED PRODUCT DEFECT ASSOCIATED WITH THE DISLOCATION AND THE RECORD WILL BE UPDATED TO NOT A COMPLAINT.
Patient problems: Joint Dislocation
MAUDE report 11393484 ↗InjuryAug 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 10405418 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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