LCS 1278-05-000Recalls & reported problems
Depuy Orthopaedics, Inc. · LCS TIBIAL INSERT MENISCAL BEARING BRIDGING BEARING SM+/STD 10mm · Class 3 · Implant
All models of LCS (45)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295020134), received between Sep 9, 2019 and Aug 29, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Naturally Worn” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn2
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY VIA TKA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT THE TIBIAL INSERT WAS SCHEDULED FOR REVISION DUE TO AGE-RELATED DETERIORATION. A SPECIFIC DATE FOR THE REVISION HAS NOT YET BEEN SET. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20096381 ↗MalfunctionSep 9, 2019Naturally Worn; Naturally Worn
THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2004 VIA TKA. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED BY REPLACING THE TIBIAL INSERT (P/N: 127805000) DUE TO WEAR OF THE TIBIAL INSERT CAUSED BY DETERIORATION OVER TIME (DATE OF REVISION SURGERY WAS UNKNOWN). NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8974830 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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