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Unitrax 6942-7-075Recalls & reported problems

Howmedica Osteonics Corp. · Neck Adjustment Sleeve · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327013474), received between Sep 19, 2019 and Oct 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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.

Most reported problems

Device problems

  • Mechanical Problem2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 4, 2019Mechanical Problem; Mechanical Problem

    OCCURRED IN OR DURING HEMIARTHROPLASTY. DURING FINAL IMPLANTATION, THE C-TAPER NECK SLEEVE WOULD NOT LOCK ONTO THE C- TAPER STEM. WITH MINIMAL PRESSURE THE +5 C-TAPER NECK SLEEVE WOULD SLIDE OFF THE TRUNNION OF THE IMPLANTED STEM. THE SLEEVE FIT AND SECURED TO THE UNITRAX HEAD PROPERLY, BUT WHEN PUT ONTO THE TRUNNION, IT WOULD EASILY SLIDE OFF. THIS CAUSED ABOUT A 10 MINUTE DELAY TO TRY AND PROBLEM SOLVE, AND ULTIMATELY NEEDED TO OPEN A DIFFERENT SLEEVE. WE HAD TO OPEN A +10 SLEEVE AND THAT WORKED PROPERLY. UPDATE 10/SEPTEMBER/2019 WG: SPOKE TO REP. REP WAS PRESENT IN THE OPERATING ROOM. AT THE TIME OF EVENT. THE IMPLANT LABEL WAS NOT APPLIED TO THE USAGE SHEET. NO FURTHER INFORMATION WILL BE AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9155933 ↗
  • MalfunctionSep 19, 2019Mechanical Problem; Mechanical Problem

    PRIMARY PROCEDURE, RIGHT HEMI HIP. THE SURGEON REPORTED THAT THE 44MM UNITRAX HEAD WITH +5 SLEEVE WOULD NOT LOCK ONTO THE TRUNNION OF THE OMNIFIT MFX STEM. A 45MM UNITRAX HEAD AND +0 SLEEVE WHICH WERE ALREADY WAITING IN THE O.R. WERE USED AND PERFORMED AS EXPECTED. SURGERY COMPLETED SUCCESSFULLY WITH NO DELAY. THE REP IS TRYING TO RETRIEVE THE WASTED DEVICES FROM THE HOSPITAL, AND PROVIDED THE USAGE SHEET FOR THE PROCEDURE. NO FURTHER INFORMATION WILL BE AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9087739 ↗

Other Prosthesis, hip, hemi-, femoral, metal devices

All Prosthesis, hip, hemi-, femoral, metal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.