Unitrax 6942-5-049Recalls & reported problems
Howmedica Osteonics Corp. · Head Component · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327032437), received between Feb 13, 2019 and Aug 29, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 Dislocated2
- Insufficient Device Problem Information1
Patient problems
- Joint Dislocation2
- Injury1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS PROVIDED: AS REPORTED: "PATIENT DISLOCATED HER UNIPOLAR. SHE WAS REVISED TO A RESECTION ARTHROPLASTY WITH NO IMPLANTS (GIRDLESTONE). NO REP PRESENT. NO ALLEGATIONS AGAINST THE IMPLANTS. NO FURTHER INFORMATION WILL BE MADE AVAILABLE." RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22926305 ↗InjuryOct 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISED A RIGHT HEMI HIP TO A TOTAL HIP WITH CONSTRAINED LINER DUE TO DISLOCATION. NO ALLEGATIONS AGAINST THE IMPLANTS MADE. UPDATE 30/SEPTEMBER/2022 WG: SPOKE TO REP. REP CONFIRMED THAT THE ENDOPROSTHESIS HEAD CAME OUT OF THE PATIENT'S NATIVE ACETABULUM. REP RE-CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 15648770 ↗InjuryFeb 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO PAIN. PATIENT WAS CONVERTED FROM A HEMI TO A TOTAL HIP. THE BIPOLAR COMPONENT AND FEMORAL HEAD WERE REVISED, THE STEM WAS NOT. UPDATE 21/JANUARY/2019: REP PROVIDED PRIMARY AND REVISION IMPLANT SHEETS. A UNITRAX BIPOLAR COMPONENT AND C-TAPER NECK ADJUSTMENT SLEEVE WERE REVISED TO A BIOLOX 36 +7.5 HEAD. THE STEM WAS NOT REVISED AND NO STRYKER ACETABULAR DEVICES ARE LISTED ON THE REVISION IMPLANT SHEET.
Patient problems: Injury; Pain
MAUDE report 8336280 ↗
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 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United 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 2515-3111United 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 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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