SIGMA 2024-43-000Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE LAMINA SPREADER · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295083061), received between Nov 19, 2018 and Sep 3, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Crack1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- 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.
MalfunctionSep 3, 2024Break; Break
IT WAS REPORTED THAT THE LAMINA SPREADER SPRING BROKE.
Patient problems: Insufficient Information
MAUDE report 20124871 ↗MalfunctionMar 28, 2024Crack; Crack
IT WAS REPORTED THAT THE T HANDLE CRACKED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18990617 ↗MalfunctionFeb 19, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT LAMINA SPREADER WOULD NOT STAY IN THE LOCKED POSITION. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730927 ↗MalfunctionNov 19, 2018Break; Break
IT WAS REPORTED THAT THE UNI-TRAY LAMINA SPREADER BROKE DURING SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8085121 ↗
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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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