Unitrax 6942-7-060Recalls & reported problems
Howmedica Osteonics Corp. · Neck Adjustment Sleeve · Class 2 · Implant
All models of Unitrax (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327013450), received between May 10, 2017 and Jun 28, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Fitting Problem1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient2
- Bone Fracture(s)1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2017Material Deformation; Device Operates Differently Than Expected; Material Deformation
IT WAS REPORTED THAT DURING A PRIMARY HEMI HIP ARTHROPLASTY (SIDE NOT PROVIDED) THE UNIPOLAR HEAD AND SLEEVE WOULD NOT ENGAGE ON THE STEM.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 6673255 ↗MalfunctionMay 10, 2017Mechanical Problem; Fitting Problem; Mechanical Problem
IT WAS REPORTED BY THE SALES REPRESENTATIVE VIA PHONE THAT DURING A PRIMARY SURGERY FOR A FRACTURED HIP, THAT THE TAPER HEAD WOULD NOT LOCK ONTO THE STEM. THE PHYSICIAN TRIED 3 TIMES. THE PHYSICIAN USED A BIPOLAR HEAD THE SAME SIZE AND IT WORKED.
Patient problems: Bone Fracture(s); No Consequences Or Impact To Patient
MAUDE report 6559001 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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