TRUMATCH 420579Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295430803), received between Jul 10, 2019 and May 1, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 10, 2021Terminated

   Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.

   Z-2395-2021 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE LACK OF ACCURACY OF THE PIN GUIDE DUE TO THE POSTERIOR SLOPE OVER 10. EVENT OCCURRED DURING INTRA-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941707 ↗
• MalfunctionMay 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROXIMAL TIBIA RESECTION WAS CUT WITH APPROXIMATELY 2.5 DEGREES OF ANTERIOR SLOPE. THE PROPOSED PLAN USING THE TIBIA PIN GUIDE WAS SET TO 3 DEGREES OF POSTERIOR SLOPE.

  Patient problems: Insufficient Information

  MAUDE report 19288208 ↗
• MalfunctionJul 28, 2021Computer Software Problem; Patient-Device Incompatibility; Computer Software Problem; Patient-Device Incompatibility

  PATIENT PLAN DID NOT ALIGN WITH PATIENT ANATOMY, PER SALES REP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240988 ↗
• MalfunctionJul 28, 2021Computer Software Problem; Patient-Device Incompatibility; Computer Software Problem; Patient-Device Incompatibility

  PATIENT PLAN DID NOT ALIGN WITH PATIENT ANATOMY, PER SALES REP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240933 ↗
• MalfunctionJul 9, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE TRUMATCH ATTUNE PS PIN GUIDE ON FEMORAL SIDE DID NOT FIT. SURGEON SPENT 5 MINUTES TRYING TO FIT GUIDE ON TO PATIENT FEMUR. GUIDE WOULD NOT FIT WHICH RESULTED IN USING MANUAL INSTRUMENTS. A SURGICAL DELAY OF 10 MINUTES WAS NOTED.

  Patient problems: Not Applicable

  MAUDE report 10252387 ↗
• MalfunctionJul 10, 2019Incorrect Measurement; Incorrect Measurement

  THE FEMUR GUIDE FIT GREAT BUT WHEN HE MEASURED THE POSTERIOR MEDIAL BONE CHIP HE MEASURED 15MM BUT THE PLAN CALLED FOR 12.1MM RESECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775733 ↗