Skip to content

Unitrax 6942-7-065Recalls & reported problems

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

Adverse event reports
6
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327013467), received between Sep 24, 2018 and Aug 22, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Corroded” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Corroded1
  • Device Dislodged or Dislocated1
  • Difficult to Insert1
  • Fitting Problem1
  • Inadequacy of Device Shape and/or Size1
  • Mechanical Problem1
  • Positioning Problem1

Patient problems

  • No Consequences Or Impact To Patient3
  • No Known Impact Or Consequence To Patient2
  • Foreign Body Reaction1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 22, 2022Corroded; Corroded

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS CONVERTED FROM A HEMI TO A TOTAL HIP DUE TO THE MODULAR ENDO HEAD MIGRATING THROUGH THE ACETABULUM. INTRA-OPERATIVELY, METAL STAINING WAS NOTED AT THE JUNCTION OF THE STEM AND SLEEVE, AND SOME METAL STAINING IN THE SURROUNDING TISSUE.

    Patient problems: Foreign Body Reaction

    MAUDE report 15266745 ↗
  • MalfunctionMay 21, 2019Mechanical Problem; Mechanical Problem

    C-TAPER SLEEVE WOULD NOT STAY ENGAGED TO THE TRUNION. UPDATE: "SITUATION WAS RESOLVED BY OPENING ANOTHER UHT UNIPOLAR HEAD AND A STANDARD C-TAPER SLEEVE." DELAY IN SURGERY: 5-7 MIN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8627581 ↗
  • MalfunctionOct 25, 2018Difficult to Insert; Difficult to Insert

    OPENED A UNITRAX SLEEVE, CTPR, +0, REF (B)(4), LOT 58877002. SLEEVE WAS PLACED IN UNITRAX HEAD, CORRECTLY, THEN THE SURGEON ATTEMPTED TO IMPACT IT ON A SIZE 5, OMNIFIT, CTPR STEM. TAPER DID NOT ENGAGE. SLEEVE SPUN AROUND ON TRUNNION OF STEM. CTPR TRIALING FIT CORRECTLY PRIOR AND DURING SITUATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8005047 ↗
  • MalfunctionOct 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    TAPER SLEEVE WOULD NOT STAY ENGAGED TO THE TRUNNION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7969800 ↗
  • MalfunctionOct 5, 2018Fitting Problem; Positioning Problem; Fitting Problem; Positioning Problem

    PRIMARY PROCEDURE, HIP. IT WAS REPORTED THE UNITRAX C-TAPER SLEEVE WOULD NOT STAY ON THE STEM WHEN IMPACTED ON. HEAD REMAINED IMPACTED ON THE SLEEVE. THE CONSTRUCT WAS REMOVED AND A C-TAPER LFIT HEAD WAS IMPLANTED INSTEAD. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7938396 ↗
  • MalfunctionSep 24, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    PRIMARY PROCEDURE, HIP. IT WAS REPORTED THE UNITRAX C-TAPER SLEEVE WOULD NOT STAY ON THE STEM WHEN IMPACTED ON. HEAD REMAINED IMPACTED ON THE SLEEVE. THE CONSTRUCT WAS REMOVED AND A C-TAPER LFIT HEAD WAS IMPLANTED INSTEAD. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7903314 ↗

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.