SIGMA 9505-01-264Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FIXED REFERENCE POSTERIOR ROTATION GUIDE 0 DEG · 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 10603295225676), received between Apr 29, 2020 and Oct 27, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (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
- Material Discolored1
- Material Twisted/Bent1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
DURING CASE THE FEMORAL SIZER AND THE FEMORAL POSTERIOR REFERENCING FEMORAL ROTATION GUIDES WERE NOT GOING TOGETHER EASILY. THEN ONCE WE GOT IT ON IT WAS EXTREMELY DIFFICULT TO TAKE OFF. HAD TO USE A HOHMAN TO REMOVE THE FEMORAL ROTATION GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available
MAUDE report 10741494 ↗MalfunctionApr 29, 2020Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent
INSTRUMENTS SHOW SIGNS OF WEAR AND DISCOLOURATIONS. NOTICED DURING CLEANING PROCESS. NO SURGICAL AFFECT. NO PATIENT AFFECT. INSTRUMENTS ARE FURTHER IN USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10012586 ↗
Other TEMPLATE devices
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- 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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