Skip to content

SIGMA 97-0454Recalls & reported problems

Depuy (Ireland) · SIGMA TIBIAL INSERT FIXED BEARING CURVED PLUS 3 17.5mm XLK · Class 2 · Implant

All models of SIGMA (380)

Data updated Oct 16, 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 10603295250586), received between Dec 13, 2022 and Dec 13, 2022 — classified as 1 injury.

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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Joint Laxity1

Recent adverse event reports

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

  • InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT FELT UNSTABLE. DR. PERFORMED SURGERY TO REPLACE POLY WITH A 20 MM POLY. DURING SURGERY, THE TRIAL 20 MM POLY WOULD NOT GIVE STABILITY. HE THEN DECIDED TO REPLACE TIBIA WITH A 15 MM THICK MBT THICK TIBIAL TRAY AND A RP CR POLY. SURGERY WAS A SUCCESS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

    Patient problems: Joint Laxity

    MAUDE report 15969701 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page