Unitrax 6942-5-046Recalls & reported problems
Howmedica Osteonics Corp. · Head Component · Class 2 · Implant
All models of Unitrax (20)
Data updated Oct 16, 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 07613327032406), received between Jan 8, 2021 and Nov 11, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Unstable” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Unstable1
Patient problems
- Unspecified Infection2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2024Unstable; Unstable
PT. PRESENTED WITH "PAIN AND INSTABILITY" FOLLOWING A RIGHT HEMIARTHROPLASTY ON (B)(6). DR. OPTED TO REVISE THE HEMI BUT UPON CLINICAL ASSESSMENT OF THE HIP INTRA-OP NO ANATOMICAL OR FUNCTIONAL ISSUES COULD BE DETERMINED. DR. OPTED TO REVISE HER UNIPOLAR-CONSTRUCT TO A BIPOLAR-CONSTRUCT. STEM WAS LEFT IN-SITU. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES; NO FURTHER INFO AVAILABLE.
Patient problems: Pain
MAUDE report 20651278 ↗InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT UNIPOLAR HIP WAS REVISED DUE TO INFECTION. A UNITRAX HEAD AND SLEEVE WERE REVISED.
Patient problems: Unspecified Infection
MAUDE report 15705261 ↗InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SUSPECTED INFECTION. A SIZE 46 UNIPOLAR HEAD AND -4 SLEEVE WERE EXCHANGED FOR SAME-SIZE IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 11140703 ↗
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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