SIGMA LCS COMPLETE POROCOAT 1294-34-150Recalls & reported problems
Depuy (Ireland) · SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 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 10603295025894), received between Sep 7, 2017 and May 7, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Loss of Osseointegration1
- Osseointegration Problem1
Patient problems
- Unspecified Infection2
- Ambulation or Postural Difficulties1
- Hemorrhage/Blood Loss/Bleeding1
- Inadequate Osseointegration1
- Insufficient Information1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2025Osseointegration Problem; Osseointegration Problem
(B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO FEMORAL (IMPLANT TO BONE) AND TIBIAL LOOSENING (IMPLANT TO BONE). AT REMOVAL THE TIBIAL INSERT SHOWED MINOR YELLOWING.
Patient problems: Insufficient Information
MAUDE report 21979294 ↗InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(4). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SYNOVIAL PINCH VS INFECTION / HEMARTHROSIS DEVICE RELATEDNESS: POSSIBLY. PROCEDURE RELATEDNESS: DEFINITELY NOT. DATE OF EVENT: 14/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20777605 ↗InjuryAug 29, 2018Loss of Osseointegration; Loss of Osseointegration
PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA AT THE BONE TO IMPLANT INTERFACE. LCS PRESSFIT FEMUR, TIBIA, POLY AND PATELLA WERE REMOVED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 7826148 ↗InjurySep 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6849189 ↗
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.
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