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OMEGA 597024SRecalls & reported problems

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

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154325085), received between Sep 10, 2015 and Feb 14, 2022 — classified as 2 injuries, 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
  • Device Contaminated During Manufacture or Shipping1
  • Inadequacy of Device Shape and/or Size1

Patient problems

  • Deformity/ Disfigurement1
  • Insufficient Information1
  • No Code Available1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 14, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    THE CUSTOMER REPORTED A FOREIGN BODY IN AN OMEGA IMPLANT BOX.

    Patient problems: Insufficient Information

    MAUDE report 13524633 ↗
  • InjuryDec 19, 2016Break

    ON (B)(6) 2016, THE SUBJECT FELL AT HOME SUSTAINING A FEMUR NECK FRACTURE OF THE LEFT HIP. SUBJECT WAS ADMITTED TO HOSPITAL. RADIOGRAPHS SHOWED FAILURE OF FIXATION FOR RIGHT HIP FRACTURE. SUBJECT UNDERWENT RIGHT HEMIARTHROPLASTY ON (B)(6) 2015 WITH SLIDING HIP SCREW FIXATION. SUBJECT HAS NOT BEEN DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED, "THE BROKEN DEVICE CURRENTLY REMAINS IN SITU. IT HAS NOT BEEN DECIDED YET WHAT EXACTLY WILL HAPPEN TO THE BROKEN DEVICE. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY AND WILL BE DISCHARGED HOME SHORTLY. IT WAS FELT PRUDENT NOT TO TRY AND DO ANYTHING ACTIVELY WITH THE BROKEN DEVICE UNTIL THE RECENT HIP SURGERY HAS HEALED PROPERLY. IF THE PATIENT IS NOT IN PAIN THEN IT MAY BE THAT THE BROKEN DEVICE REMAINS IN SITU ¿IT DOES DEPEND ON THE PATIENT. SHE WILL BE REVIEWED IN OUTPATIENT CLINIC IN SIX WEEKS WHEN A DECISION MAY BE MADE ABOUT WHAT TO DO WITH THE BROKEN DEVICE."

    Patient problems: No Code Available

    MAUDE report 6185583 ↗
  • InjurySep 10, 2015Inadequacy of Device Shape and/or Size

    ON (B)(6) 2015, PATIENT RETURNED TO CLINIC AT 15 MONTHS POST-SURGERY. A SLIGHT DIFFERENCE IN LEG LENGTHS, MEASURED TO BE 1.5CM, WAS NOTICED. PRESCRIPTION FOR A SHOE LIFT WAS GIVEN.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 5069350 ↗

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.