SIGMA 2024-11-408Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE UNI TIBIAL TRIAL SZ 4 8mm · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295082835), received between May 20, 2019 and Oct 23, 2020 — classified as 2 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.
Most reported problems
Device problems
- Break2
- Entrapment of Device1
Patient problems
- No Consequences Or Impact To Patient2
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2020Break; Break
IT WAS REPORTED THAT THE INSERT TRIAL BROKE UPON REMOVAL. ALL PIECES REMOVED FROM PATIENT. NO FURTHER INFORMATION AVAILABLE. NEEDS REPLACEMENT TO DUKE .
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10726355 ↗MalfunctionMay 20, 2019Break; Entrapment of Device; Break; Entrapment of Device
THERE IS NO ALLEGATION OF EMBEDDED DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8625315 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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