SIGMA 2011-03-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295081715), received between Jul 20, 2017 and Jun 9, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS A 5 MINUTE DELAY, NO PIECES WERE LEFT BEHIND. DEPUY PRODUCTS WERE USED DURING REVISION.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10134569 ↗
• MalfunctionSep 11, 2019Display Difficult to Read; Material Twisted/Bent; Display Difficult to Read; Material Twisted/Bent

  IT WAS REPORTED THAT THE HEX HEAD OF THE BOLTS WERE STRIPPED AND NEEDS TO BE REPLACED. THE LOT NUMBERS COULD NOT BE READ. REPLACEMENTS TO BE SENT TO TRIDENT VIA FEDEX P1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8998335 ↗
• MalfunctionJul 17, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TC3 SLEEVE ADAPTER BOLT TRIAL AND DRIVER SHAFT ARE WORN AND NO LONGER THREADING INTO EACH OTHER. HAD TO OPEN ANOTHER INSTRUMENT SET TO USE. 10 MINS ADDED TO CASE. ALL PARTS REMOVED.

  Patient problems: No Code Available

  MAUDE report 7694670 ↗
• MalfunctionApr 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DISTAL FEMORAL BLOCK ATTACHMENT/ CONNECTOR IS "STICKY", SLEEVE BOLT NOT THREADING IN SMOOTHLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439483 ↗
• MalfunctionSep 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SLEEVE SCREW FROM THE SIGMA KNEE REVISION SET WILL NOT THREAD INTO ANY OF THE BOX TRIALS.

  Patient problems: No Information

  MAUDE report 6878459 ↗
• MalfunctionJul 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HEAD OF THE SLEEVE BOLT STRIPPED DURING THE CASE.

  Patient problems: No Information

  MAUDE report 6728657 ↗