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SIGMA LCS COMPLETE POROCOAT 1294-32-160Recalls & reported problems

Depuy (Ireland) · SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 6 CEMENTLESS · Class 3 · Implant

All models of SIGMA LCS COMPLETE POROCOAT (11)

Data updated Oct 18, 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 10603295025726), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Osseointegration Problem1

Patient problems

  • Inadequate Osseointegration1

Recent adverse event reports

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

  • InjuryNov 16, 2021Osseointegration Problem; Osseointegration Problem

    REVISION KNEE SURGERY FOR ASEPTIC LOOSENING OF FEMORAL, TIBIAL AND PATELLA IMPLANTS OF THE LEFT KNEE. BONE SCANS HIGHLIGHTED "HOT" ON THE ABOVE THREE COMPONENTS. THE IMPLANTS WERE EXPLANTED AND REPLACED WITH AN ATTUNE REVISION KNEE SYSTEM.

    Patient problems: Inadequate Osseointegration

    MAUDE report 12820044 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices

All Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices →

Sources and updates

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