SIGMA LCS COMPLETE POROCOAT 1294-34-120Recalls & reported problems
Depuy (Ireland) · SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 2 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295025856), received between May 6, 2021 and Aug 27, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem2
Patient problems
- Inadequate Osseointegration2
- Pain2
- Bone Notching1
- Cyst(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Osseointegration Problem
It was reported that original surgery date was unknown. Patient needed complete revision for tibial bone loss. Multiple large cysts had developed and tibial component was loose. Further bone loss was experienced during the removal process. Attune revision components implanted without issue. Loosening was at the bone to implant (Non-Cemented) interface.Affected Side: Left Knee.
Patient problems: Bone Notching; Cyst(s); Inadequate Osseointegration; Pain
MAUDE report 50476589 ↗InjuryMay 6, 2021Osseointegration Problem; Osseointegration Problem
PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT KNEE.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 11785629 ↗
Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices
- ATTUNE 1506-10-005Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing442 reports
- ATTUNE 1506-10-004Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing442 reports
- ATTUNE 1518-20-038Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3 deaths393 reports
- LCS SIGMA 1294-33-130Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 recall310 reports
- ATTUNE 1518-20-035Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing342 reports
- P.F.C. SIGMA 96-0102Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 death319 reports
- ATTUNE 1518-20-041Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing308 reports
- ATTUNE 1506-10-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing284 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page