NA 2294-35-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295113447), received between Oct 10, 2018 and Jun 22, 2021 — classified as 2 malfunctions.

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

• MalfunctionJun 22, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT DURING A COMPLEX KNEE USING THE TC3 AND REVISION MBT SYSTEM THE SLEEVE TRIALS ARE NOT CONNECTING TO THE TRAY TRIALS. SURGEON FEELS THE SET IS WORN OUT, TOO OLD AND THE TRIALS NEED TO BE REPLACED. REQUESTED ALL SIZES TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042044 ↗
• MalfunctionOct 10, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 3 AND 4 SIGMA REV TIBIA TRIAL TRAYS WERE NOT ENGAGING WITH THE STEM TRIALS. WHILE PREPARING THE TIBIA THAT HUDSON ADAPTER WAS NOT ENGAGING THE PRIMARY CONICAL REAMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953615 ↗