SIGMA 96-3341Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295246299), received between Dec 28, 2017 and Feb 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2019Break; Break

  IT WAS REPORTED THAT DURING TRIALING OF THE TC3 RP INSERT TRIAL, THE SURGEON WAS ATTEMPTING TO REMOVE THE TRIAL AND BENT THE METAL POST TO WHERE IT BENT AND BECAME UNUSABLE FOR FUTURE CASES. DURING ASSEMBLY OF THE STEM AND TIBIA IMPLANT, THE ASSEMBLY WRENCH BROKE AND WOULD NOT LOCK AROUND THE STEM AND THE DIAL WOULD JUST CONTINUE TO SPIN WITHOUT LOCKING. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297482 ↗
• MalfunctionDec 28, 2017Bent; Bent

  IT WAS REPORTED THAT THE SILVER PEG ON THE BOTTOM OF THE TC3 RP INSERT IS CROOKED/BENT. THEREFORE IT NO LONGER SITS PRECISELY ON THE TOP OF THE TIBIAL TRAY TRIAL OR REAL MBT REV TIBIAL TRAY.

  Patient problems: No Information

  MAUDE report 7151644 ↗