SIGMA 2024-40-400Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE PARTIAL KNEE - UNI TIBIAL STYLUS · 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 10603295082996), received between Mar 7, 2019 and Nov 17, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility1
- Mechanical Jam1
- Naturally Worn1
- Physical Resistance/Sticking1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2022Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED: A. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO DELAY. B. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO C. DID ALL REPORTED PRODUCTS BREAK INTO TWO? IF YES, WE'RE ALL PIECES RETRIEVED FROM THE PATIENT? NO ¿ JAMMED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15816463 ↗MalfunctionAug 2, 2021Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY AND THE CAPTURE SAW FEATURE WAS WORN SO THAT THE CUT WAS INACCURATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12258558 ↗MalfunctionFeb 18, 2020Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
IT WAS REPORTED THAT THE STYLUS TOOL IN THE UNI TIBIAL TRAY WILL NOT MOVE FROM CURRENT POSITION SEEMS STUCK OR BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9722079 ↗MalfunctionMar 7, 2019Positioning Problem; Positioning Problem
THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. IN-HOUSE ENGINEERING EVALUATION: EXAMINATION OF THE RETURNED DEVICE FOUND THE LOCKING MECHANISM WILL NOT LOCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8400440 ↗
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- 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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