Biomet® Hip System 163668Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00887868308321), received between Dec 7, 2021 and Jul 8, 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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation4
- Fall2
- Pain1
- Unspecified Tissue Injury1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 22449450 ↗InjuryApr 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO A FALL CAUSING A DISLOCATION. NO ADDITIONAL INFORMATION.
Patient problems: Fall; Joint Dislocation
MAUDE report 16784217 ↗InjuryOct 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO A FALL CAUSING A DISLOCATION.
Patient problems: Fall; Joint Dislocation
MAUDE report 15668417 ↗InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A TOTAL HIP STUDY PATIENT (36) UNDERWENT REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO PAINFUL PSOAS IMPINGEMENT CONFIRMED BY ULTRASOUND. NO ADDITIONAL INFORMATION.
Patient problems: Pain; Unspecified Tissue Injury
MAUDE report 14013569 ↗InjuryDec 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED THEIR LEFT HIP APPROXIMATELY 11 DAYS POST TOTAL HIP ARTHROPLASTY. APPROXIMATELY 3 DAYS LATER THE PATIENT UNDERWENT A REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 12956003 ↗
Other Prosthesis, hip, femoral component, cemented, metal devices
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- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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