TruMatch 431001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295451907), received between Apr 21, 2022 and Oct 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Patient-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 16, 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.

• MalfunctionOct 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE MEDIAL SIDE FROM MEMORY STATED 3MM ISH CUT AND 9 FROM HIGH. BECAUSE OF TIBIAL WEAR MEDIAL/POSTERIOR IT WAS A 12MM CUT TO AVOID AIR SWING. WE FOUND THIS OUT INTRAOPERATIVELY BUT DID SAY WHEN HE LOOKED AT PLAN IT WAS NOT ACCURATE AND QUESTIONED WHERE YOU TOOK LANDMARKS PARTICULARLY ON THE MEDIAL SIDE OF TIBIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366235 ↗
• MalfunctionApr 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT SURGEON ONLY REMOVED 5MM OFF THE MEDIAL DISTAL FEMORAL CONDYLE LEAVING THE PATIENT FLEXED IN EXTENSION. THE DISTAL FEMORAL CUTTING GUIDE WAS SET AT 8 DEGREES OF VALGUS AND 9MM OFF THE DISTAL FEMORAL CONDYLE. WE NEEDED TO RECUT THE DISTAL FEMUR AND PROXIMAL TIBIA TWICE. THE PATIENT ALSO LOOKED LIKE HE HAD A SLIGHT FLEXION CONTRACTOR PRIOR TO OPERATING, WAS THIS MISSED IN THE CT?"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171309 ↗