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Omnifit 2042-2654Recalls & reported problems

Howmedica Osteonics Corp. · 20degrees Series II Insert · Class 2 · Implant

All models of Omnifit (43)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540036063), received between Apr 30, 2019 and Apr 30, 2019 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

Patient problems

  • Injury1
  • Joint Dislocation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PATIENT HIP DISLOCATING, LINER AND HEAD EXPLANTED. RE-IMPLANTED NEW HEAD, LINER, AND SCREW.

    Patient problems: Injury; Joint Dislocation

    MAUDE report 8565446 ↗

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

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Sources and updates

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