SIGMA 2011-03-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295081326), received between Sep 10, 2018 and Feb 13, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIGHTENING SCREW DOES NOT LOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9709941 ↗
• MalfunctionJan 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT UPON DISASSEMBLY OF A FEMORAL TRIAL IT WAS NOTED THAT LOCKING MECHANISM HAD BENT. REMOVING FROM USE. NO DELAY IN CASE OR PATIENT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558720 ↗
• MalfunctionJun 24, 2019Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE PIECE THAT SCREWS INTO THE POSTERIOR ASPECT OF THE BOX WAS BROKEN OFF AND THE SCREW WAS LOST. IT CAN NOT BE USED ANYMORE AND IS COMPROMISED. THE BOX ITSELF IS BEING RETURNED BUT THE SMALL BAR THAT THE SCREW GOES INTO IS NOT BECAUSE IT WAS BROKE AND LOST. IT WAS FOUND BROKEN OFF WHEN WE OPENED FOR THE CASE, THEREFORE IT WAS NOT LOST WHILE PATIENT WAS IN THE ROOM AND WAS BROKE AND LOST IN SPD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8726479 ↗
• MalfunctionApr 1, 2019Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION OF THE INSTRUMENTS IT WAS NOTICED THAT THERE WAS SOME CRACKING AND BENDING GOING ON WITH THE FEET ON THE NOTCH TRIALS IN THE SIGMA REVISION INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470470 ↗
• MalfunctionFeb 22, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  DURING THE PROCEDURE THE BOX WOULD NOT STAY IN THE TRIAL FEMORAL COMPONENT. NO BROKEN PARTS NOTED. NO AE TO PATIENT. NO DELAY TO PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361682 ↗
• MalfunctionSep 27, 2018Break; Break

  IT WAS REPORTED THAT THE SIG HP REV TC3 BOX TRIAL SZ2 INSTRUMENT WAS BROKEN DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7915945 ↗
• MalfunctionSep 10, 2018Break; Break

  FEMORAL BOX TRIAL FEET BROKEN OFF. DISCOVERED AT FIELD WAREHOUSE LOCATION. NO FURTHER INFORMATION AVAILABLE. PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7862582 ↗