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SIGMA 9505-02-814Recalls & reported problems

Depuy (Ireland) · SIGMA HIGH PERFORMANCE FB STABILIZED INSERT TRIALS CASE · Class 1

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 10603295229421), received between Apr 4, 2019 and Apr 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (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

  • Peeled/Delaminated1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionApr 4, 2019Peeled/Delaminated; Peeled/Delaminated

    THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE COATING ON THE BRACKETS WERE DELAMINATING.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8483397 ↗

Other TRAY, SURGICAL, INSTRUMENT devices

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