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Unitrax 6942-5-048Recalls & reported problems

Howmedica Osteonics Corp. · Head Component · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327032413), received between May 8, 2019 and Apr 21, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1
  • Insufficient Device Problem Information1

Patient problems

  • Injury2

Recent adverse event reports

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

  • InjuryApr 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    AS REPORTED: "DISLOCATING HEMI HIP. CONVERTED TO A TOTAL HIP. LEFT SIDE."

    Patient problems: Injury

    MAUDE report 9980876 ↗
  • InjuryMay 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    HEMI HIP WAS ORIGINALLY REVISED (B)(6) 2019 DUE TO DISLOCATION. SURGEON REMOVED THE HEAD AND SLEEVE AND CONVERTED TO A TOTAL HIP WITH MDM. UPDATE 12/APRIL/2019: REP PROVIDED IMPLANT SHEETS FROM THE PRIMARY AND REVISION SURGERIES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

    Patient problems: Injury

    MAUDE report 8592655 ↗

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.