SIGMA 2024-11-207Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE UNI TIBIAL TRIAL SZ 2 7mm · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295082729), received between Jan 23, 2018 and May 29, 2026 — classified as 8 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
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Break
IT WAS REPORTED THAT DURING KNEE SURGERY THE SPACER SNAPPED IN HALF. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334197 ↗MalfunctionAug 22, 2024Break; Break
IT WAS REPORTED THAT ITEMS HAVE PART OF THE PLASTIC SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20042322 ↗MalfunctionMay 20, 2024Break; Break
IT WAS REPORTED THAT THE 2X7 SIGMA HP UNI TIBIAL TRIAL WAS BROKE. THERE WAS NO SURGICAL DELAY AND THERE WAS NO ADVERSE PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355001 ↗MalfunctionJan 5, 2023Break; Break
IT WAS REPORTED THAT THE DOG BONE BROKE. NOTHING WAS LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16102250 ↗MalfunctionJan 5, 2023Break; Break
IT WAS REPORTED THAT THE END OF THE SPACER WAS BROKE OFF. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16101662 ↗MalfunctionAug 29, 2019Break; Break
IT WAS REPORTED THAT THE END OF TIBIAL TRIAL WAS BROKEN INTO 2 PIECES DURING SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8945204 ↗MalfunctionJun 24, 2019Break; Break
IT WAS REPORTED THAT THE 2X7 UNILATERAL TIBIAL TRIAL WAS BROKEN INTO 2 PIECES DURING SURGERY AND ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8726677 ↗MalfunctionJan 23, 2018Break; Break
IT WAS REPORTED THAT THEY PUT THE PLASTIC SPACER INTO THE TRIAL AND IT BROKE. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7212339 ↗
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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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