SIGMA 2024-11-107Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE UNI TIBIAL TRIAL SZ 1 7mm · 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 10603295082675), received between Jun 11, 2018 and May 28, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- 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.
MalfunctionMay 28, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE TRIALING. THERE WAS NO ADVERSE AFFECTS OR TIME LOSS AND NO PART OF SIZER WAS LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22099904 ↗MalfunctionFeb 13, 2024Break; Naturally Worn; Break; Naturally Worn
THE PRODUCT DAMAGE DOCUMENTED IN THIS PC DUE TO WEAR AND TEAR WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18697500 ↗MalfunctionJan 11, 2024Break; Break
SIGMA PARTIAL KNEE INSTRUMENTS (INSERT TRIAL) BROKE INTO TWO PIECES DURING THE PROCEDURE WITH NO HARM TO THE PATIENT OR LOSS OF ANY SEGMENT. THE SURGERY WAS DELAYED 3 MINUTES WHILE OPENED THE BACKUP INSTRUMENTS, THE FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18494809 ↗MalfunctionJun 11, 2018Break; Break
IT WAS REPORTED THAT TRIAL UNI 1X 7MM TIBIAL INSERTER BROKE INTO 2 PIECES DURING SURGERY AND ALL PIECED WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7586515 ↗
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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