LCS 9505-01-118Recalls & reported problems
Depuy International Ltd · LCS HIGH PERFORMANCE INSTRUMENTS DISTAL BLOCK · Class 1
All models of LCS (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295224785), received between Jan 28, 2019 and Jul 9, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Entrapment of Device1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
(B)(6) HOSPITAL (B)(6) 2020; A CSSD TEAM MEMBER ADVISED THAT THE DISTAL CUTTING BLOCK WAS APPARENTLY A BIT STICKY DURING THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10251001 ↗MalfunctionJul 29, 2019Break; Break
HCP REPORTED THE INSTRUMENT TO BE BROKEN IN ONE OR MORE PARTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8835873 ↗MalfunctionJan 28, 2019Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT WHILE TRYING TO INSERT A PIN INTO THE DISTAL FEMORAL CUTTING BLACK, THE PIN GOT STUCK IN ONE OF THE PINHOLES. NO SURGICAL DELAY HAPPEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8282240 ↗
Other INSTRUMENT, CUTTING, ORTHOPEDIC devices
- SIGMA LCS 9505-01-230Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC95 reports
- ATTUNE 2544-00-522Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC58 reports
- SIGMA LCS 9505-01-229Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC56 reports
- SIGMA 2024-40-100Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC43 reports
- ATTUNE 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-158Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 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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