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OMEGA 597012SRecalls & reported problems

Stryker GmbH · Standard Barrel Hip Plate; Keyed · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154325054), received between Sep 19, 2023 and Sep 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Fracture1

Patient problems

  • Failure of Implant1
  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionSep 19, 2023Break; Fracture; Break; Fracture

    IT WAS REPORTED THAT A BROKEN PLATE WAS FOUND IN THE QUEENSLAND KIT ROOM. UPDATE: IT WAS CONFIRMED BY EVALUATION OF THE DEVICE THAT THE DEVICE HAD BEEN IMPLANTED AND BROKE IN THE PATIENT AND WAS REVISED.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 17777823 ↗

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

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