Unitrax 6942-5-051Recalls & reported problems
Howmedica Osteonics Corp. · Head Component · Class 2 · Implant
All models of Unitrax (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327032451), received between May 25, 2017 and Feb 23, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
Device problems
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- Injury2
- Cancer1
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO A SUPERFICIAL INFECTION (INFECTION REPORTED BY SURGEON, CLINICAL IDENTIFICATION UNKNOWN). SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT AND REVISED THE ENDO HEAD AND SLEEVE.
Patient problems: Injury; Unspecified Infection
MAUDE report 7292104 ↗InjuryMay 25, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT HAD A PROXIMAL FEMORAL UNI POLAR REPLACEMENT NINE MONTHS AGO AND RECENTLY STARTED TO DISLOCATE.
Patient problems: Cancer; Injury; Joint Dislocation
MAUDE report 6591518 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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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