NA 2294-35-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295113461), received between Jul 2, 2018 and Jun 22, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 4 most recent of 4 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 12042171 ↗
• 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 12041986 ↗
• MalfunctionApr 16, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE SIZE 5 MBT TRIAL AND 37MM MBT SLEEVE TRIAL BECAME STUCK TOGETHER DURING FINAL TRIALING OF A KNEE REVISION. THEY COULD NOT BE SEPARATED IN CPD POST OPERATIVELY. NO DELAY OR ADVERSE EVENT WAS CREATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968293 ↗
• MalfunctionJul 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE CASE, A FEW OF THE TRIALS USED DID NOT EFFECTIVELY HOLD ONTO THE STEM TRIALS. THIS DID NOT CREATE ANY MAJOR DELAYS HOWEVER TWICE THE STEM TRIAL CAME LOOSE AND HAD TO BE RETRIEVED FROM THE PATIENT'S TIBIA. FOLLOWING THE CASE, I TESTED THESE TRIALS AND BROACHES AND WILL BE RETURNING THEM TO GET NEW ONES. THE RUBBER GASKET ARE GETTING WORN OUT. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: No Code Available

  MAUDE report 7655034 ↗