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SIGMA LCS COMPLETE POROCOAT 1294-32-125Recalls & reported problems

Depuy (Ireland) · SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 2.5 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
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295025689), received between Sep 29, 2017 and Jul 25, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Loss of Osseointegration1
  • Loss of or Failure to Bond1
  • Osseointegration Problem1

Patient problems

  • Pain3
  • Bone Fracture(s)1
  • Inadequate Osseointegration1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 25, 2022Osseointegration Problem; Osseointegration Problem

    PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL TRAY AT THE BONE TO IMPLANT INTERFACE. PATIENT HAD PREVIOUS TOTAL KNEE ARTHROPLASTY WITH A LCS CONSTRUCT. REMOVED TIBIA AND INSERT AND REPLACED WITH A MBT REVISION TRAY AND A LCS COMPLETE INSERT. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

    Patient problems: Inadequate Osseointegration; Pain

    MAUDE report 15092905 ↗
  • InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PAIN. SURGERY NECESSARY.

    Patient problems: Pain

    MAUDE report 11003681 ↗
  • InjuryJun 26, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

    PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7637346 ↗
  • InjurySep 29, 2017Loss of Osseointegration; Loss of Osseointegration

    THE PATIENT WAS REVISED TO ADDRESS PROXIMAL TIBIAL FRACTURE, PAIN, AND LOOSENING OF TIBIAL TRAY. LOOSENING OCCURRED AT UNKNOWN INTERFACE.

    Patient problems: Bone Fracture(s); Pain

    MAUDE report 6904116 ↗

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Sources and updates

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