SIGMA 2024-11-308Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE UNI TIBIAL TRIAL SZ 3 8mm · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295082781), received between Mar 2, 2018 and May 27, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient4
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Break
REPLACEMENT NEEDED AS THE ITEM SNAPPED DURING SURGERY. NO TIME WAS ADDED AS THE SURGEON USED ANOTHER SIZE AVAILABLE TO HIM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304001 ↗MalfunctionAug 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE DEVICE WAS REPORTED FOR AN UNKNOWN REASON/MALFUNCTION. IT DID NOT HAPPEN IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 22816802 ↗MalfunctionAug 26, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20071242 ↗MalfunctionJun 7, 2023Break; Break
IT WAS REPORTED THAT DURING CEMENTING, WHEN THE TRIAL WAS USED FOR PRESSURIZATION, THE HANDLE SNAPPED IN TWO PIECES. BOTH PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17078131 ↗MalfunctionOct 20, 2022Break; Break
IT WAS REPORTED THAT THE TIBIAL TRIAL BROKE AFTER CEMENTING WHEN WE WERE TRAILING. NO PATIENT IMPACT AND WE PROCEEDED WITH THE CASE AS NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15639173 ↗MalfunctionSep 25, 2018Break; Break
IT WAS REPORTED THAT 3X8 PADDLE BROKE INTO 2 PIECES WHILE WAITING ON CEMENT TO DRY WHILE IMPLANTING THE TIBIA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7907622 ↗MalfunctionSep 12, 2018Break; Break
IT WAS REPORTED THAT THE 3 SIGMA HP UNI TIB TRL WERE BROKEN DURING CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7868132 ↗MalfunctionSep 12, 2018Break; Break
IT WAS REPORTED THAT THE 3 SIGMA HP UNI TIB TRL WERE BROKEN DURING CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7868127 ↗MalfunctionMar 2, 2018Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKE AS IT WAS BEING IMPACTED DURING IMPACTION. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7310441 ↗
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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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