OMEGA 597032SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154325139), received between Nov 10, 2022 and Nov 10, 2022 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryNov 10, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE PATIENT HAD A SECOND REVISION OF HIP FRACTURE WITH STRYKER'S OMEGA 3 PLATE. HER PRIMARY SURGERY WAS A NAIL AND HER FIRST REVISION SURGERY WAS A STRYKER OMEGA 3 PLATE ALSO. UPON REMOVING THE OMEGA 3 PLATE TO PUT ANOTHER ONE IN, THE SURGEON NOTICED AN UNUSUAL BREAK. HE BELIEVED THAT THIS COULD POTENTIALLY BE DUE TO A FAULTY PLATE AND ASKED FOR IT TO BE STUDIED IN THE LAB."

  Patient problems: Failure of Implant

  MAUDE report 15769512 ↗