Unitrax 6942-5-045Recalls & reported problems
Howmedica Osteonics Corp. · Head Component · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327032390), received between Jun 15, 2017 and Aug 14, 2024 — classified as 2 injuries, 2 malfunctions.
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
- Packaging Problem2
- Device Contamination with Chemical or Other Material1
Patient problems
- Joint Dislocation2
- No Consequences Or Impact To Patient2
- Injury1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT IS STATUS POST RIGHT HEMI ARTHROPLASTY REVISION DUE TO MULTIPLE DISLOCATIONS. EXPLANTS INCLUDED UNITRAX HEAD AND V40 SLEEVE. NO ADDITIONAL DETAILS PROVIDED BY THE FACILITY.
Patient problems: Joint Dislocation
MAUDE report 19980273 ↗InjuryMar 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO A DISLOCATED HEMI CONSTRUCT. THE PATIENT WAS REVISED TO A TOTAL HIP.
Patient problems: Injury; Joint Dislocation
MAUDE report 7373896 ↗MalfunctionSep 14, 2017Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING A PRIMARY IMPLANT PROCEDURE FOR PATIENT'S RIGHT HIP, IMPLANT WAS OPENED. OUTER PACKAGING WAS INTACT WITH NO DAMAGE. NURSE REPORTED THAT THE OUTER BLISTER WAS TORN. SURGICAL TECH REPORTED THAT THE INNER BLISTER WAS TORN. SURGEON ELECTED TO NOT USE THE IMPLANT DUE TO STERILITY CONCERNS. AS A SECOND IMPLANT WAS IMMEDIATELY AVAILABLE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE AFFECTS TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6865273 ↗MalfunctionJun 15, 2017Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
OPENED STERILIZED IMPLANT, WAS SITTING ON TABLE FOR A WHILE BUT THEN NOTICED A WHITE PRODUCT ON INSIDE OF UNITRAX HEAD. DOES NOT BELIEVE CEMENT WAS ON IT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 6645750 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.