TRUMATCH 42-0907Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295384823), received between Jul 17, 2020 and Apr 17, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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-2397-2021 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Device-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SCRUB TECHS WERE HAVING ISSUES ATTACHING THE 2-PRONGED ATTACHMENT PIECE TO THE TIBIAL PIN BLOCKS BECAUSE THE HOLES SEEM TO BE MANUFACTURED SMALLER THAN PREVIOUSLY. IT HAS ALSO CREATED ISSUES FOR THE SURGEONS NOT BEING ABLE TO VISUALIZE THEIR ALIGNMENT AND SLOPE BECAUSE THE METAL PIECE WON¿T SIT FLUSH. A COUPLE OF BLOCKS HAVE BROKEN AT THAT JUNCTURE, AS THE SCRUB TECHS USE METAL INSTRUMENTS ATTEMPTING TO TAP IT IN FLUSH.

  Patient problems: Insufficient Information

  MAUDE report 24916572 ↗
• MalfunctionApr 11, 2026Nonstandard Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCRUB TECHS WERE HAVING ISSUES ATTACHING THE 2-PRONGED ATTACHMENT PIECE TO THE TIBIAL PIN BLOCKS BECAUSE THE HOLES SEEM TO BE MANUFACTURED SMALLER THAN PREVIOUSLY. IT HAS ALSO CREATED ISSUES FOR THE SURGEONS NOT BEING ABLE TO VISUALIZE THEIR ALIGNMENT AND SLOPE BECAUSE THE METAL PIECE WON¿T SIT FLUSH. A COUPLE OF BLOCKS HAVE BROKEN AT THAT JUNCTURE, AS THE SCRUB TECHS USE METAL INSTRUMENTS ATTEMPTING TO TAP IT IN FLUSH.

  Patient problems: Insufficient Information

  MAUDE report 24852785 ↗
• MalfunctionApr 11, 2026Nonstandard Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCRUB TECHS WERE HAVING ISSUES ATTACHING THE 2-PRONGED ATTACHMENT PIECE TO THE TIBIAL PIN BLOCKS BECAUSE THE HOLES SEEM TO BE MANUFACTURED SMALLER THAN PREVIOUSLY. IT HAS ALSO CREATED ISSUES FOR THE SURGEONS NOT BEING ABLE TO VISUALIZE THEIR ALIGNMENT AND SLOPE BECAUSE THE METAL PIECE WON¿T SIT FLUSH. A COUPLE OF BLOCKS HAVE BROKEN AT THAT JUNCTURE, AS THE SCRUB TECHS USE METAL INSTRUMENTS ATTEMPTING TO TAP IT IN FLUSH.

  Patient problems: Insufficient Information

  MAUDE report 24847975 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT TRUMATCH CT FEM CUT TIB PIN R AND HP EM TIBIAL JIG UPROD WERE INVOLVED IN A REPORTED EVENT. DURING A PROCEDURE, THE HP DOWNROD DID NOT FULLY ENGAGE WITH THE TRUMATCH TIBIA PIN GUIDE, ONLY INSERTING ABOUT HALFWAY. DESPITE THIS, ALIGNMENT WAS ACHIEVED TO SATISFACTION, AND THERE WERE NO SURGICAL DELAYS OR ISSUES. THERE WAS NO PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402735 ↗
• MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087543 ↗
• MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087540 ↗
• MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087360 ↗
• MalfunctionJun 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRUMATCH TIBIAL PIN GUIDE DID NOT ATTACH TO THE TIBIAL UPROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087338 ↗
• MalfunctionFeb 2, 2021Incorrect Measurement; Incorrect Measurement

  DURING BILATERAL TKA, THERE WAS A MAJOR ISSUE WITH THE EXTERNAL ROTATION ON BOTH FEMORAL BLOCKS. THE BLOCKS WERE EXTERNALLY ROTATED. AFTER NOTICING THERE WAS TOO MUCH EXTERNAL ROTATION, SURGEON HAD TO USE THE REGULAR SIZING DEVICE TO DIAL IT BACK DOWN TO NORMAL, DELAYING EACH KNEE BY ABOUT 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11265884 ↗
• MalfunctionJul 17, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT WHILE THE FEMUR BLOCK WORKED LIKE IT¿S SUPPOSED TO, THE TIBIA BLOCK PUT THE TIBIA INTO VARUS, SO NOW HE¿S HAVING TO RECUT AND REBALANCE THE KNEE. CURRENTLY TRIALING WITH A 10 POLY WHICH HE ALMOST NEVER GETS TO. HE ALSO JUST CALLED XRAY INTO THE ROOM TO CHECK HIS ALIGNMENT. 4 OUT OF THE LAST 5 CASES NOW HE¿S HAD ISSUES WITH THE TRUMATCH BLOCKS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290251 ↗
• MalfunctionJul 17, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED AS " EVENT DESCRIPTIONS: TMK23137, KK, NOT ENOUGH EXTERNAL ROTATION IN SURGERY. TMK23228, MT, TOO MUCH EXTERNAL ROTATION IN SURGERY. TMK23258, JG, LEFT KNEE, FOLLOWING UP ON ROTATION ISSUE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290236 ↗