TRUMATCH 420916Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295384861), received between Jul 30, 2018 and Feb 26, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (13 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-2399-2021 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Patient-Device Incompatibility

  CASE TODAY THAT DID NOT GO GREAT. SEEMED TO UNDER RESECT, SEEMED EXCESSIVELY ER AND DISTAL FEMORAL CUT WAS LIGHT LATERALLY. HAD TO TAKE MORE TIBIA IN ORDER TO CREATE SPACE. JOINT RECONSTRUCTION SIDE AFFECTED: RIGHT SIDE QUANTITY AFFECTED: 1. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456131 ↗
• MalfunctionFeb 24, 2026Patient-Device Incompatibility

  SURGEON WAS NOT HAPPY WITH THE FIT OF THE TIBIAL BLOCK ON THIS PATIENT. WHEN THE LATERAL SIDE ENGAGED, THE MEDIAL SIDE WAS WAY OFF. WE WERE FORCED TO ABORT TO MANUAL INSTRUMENTATION. THERE WAS NO PATIENT OR USER HARM. AFFECTED: RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431547 ↗
• MalfunctionAug 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE TIBIAL RESECTION WAS VERY CONSERVATIVE DESPITE THE PLAN RECOMMENDING A 10MM POLY. ALSO, IT LOOKED LIKE THERE WAS SIGNIFICANT INTERNAL ROTATION RATHER THAN THE 3D EXTERNAL PLANNED. SURGICAL TEAM HAD TO RESORT TO STANDARD INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720019 ↗
• MalfunctionSep 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE CASE STARTED AS USUAL, WITH A STANDARD APPROACH TO REMOVING SOFT TISSUES, FAT PAD ETC. SURGEON HAS DONE SEVERAL TRUMATCH CASES OVER THE YEARS AND UNDERSTANDS NOT TO REMOVE ANY OSTEOPHYTES BEFORE PLACING THE BLOCKS. BOTH FEMORAL AND TIBIAL GUIDES WERE OPENED AFTER CHECKING THAT THE PATIENT MATCHED THE TRUMATCH REFERENCE FOR THE CASE. THE FEMORAL BLOCK WAS OFFERED UP TO THE FEMUR FIRST AND IT BECAME CLEAR VERY QUICKLY THAT SOMETHING WAS INCORRECT ON THE ANTERIOR SURFACE. WE CHECKED THE PROPOSAL AND THEN CHECKED THE BLOCKS AND THE PROPOSAL DID NOT OFFER A PATHWAY TO SECURE THE BLOCKS. THE SURGEON TRIED TO MANIPULATE THE BLOCK TO FIT BUT IT BECAME CLEAR THAT HE WOULD NEED TO CUT OSTEOPHYTES FROM THE ANTERIOR MEDIAL COMPARTMENT OF THE KNEE. THIS WAS DONE WITH MINIMAL AMOUNTS BEING TAKEN THEN THE BLOCK WAS OFFERED UP FOR FITMENT, IT WOULDN'T FIT, SO MORE BONE WAS TAKEN ON ANOTHER 3 OCCASIONS, TO THE POINT WHERE THE SURGEON WAS UNABLE TO MAKE ANY ADDITIONAL CUTS AS HE HAD REACHED THE PATIENT'S TRUE ANATOMY. THE BLOCK AT THIS POINT WAS STILL SITTING PROUD OF THE POSTERIOR CONDYLES, THE DISTAL SURFACE AND THE ANTERIOR BY AROUND 12MM, SO NOT IDEAL FOR THE PIN POSITIONS. SURGEON THEN DECI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289845 ↗
• MalfunctionMay 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE EXACT ALLEGATION AGAINST THE DEVICE? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION? NO DAMAGE TO THE DEVICE. DEVICE SEEMED TO UNDER-CUT THE BONE RELATIVE TO WHAT IT WAS PLANNED AND DESIGNED TO DO. THE TRUMATCH BLOCKS ARE A SINGLE USE BESPOKE RESECTION GUIDE CREATED OFF PATIENT SPECIFIC CT SCANS BY THE TRUMATCH TEAM IN WARSAW. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? DELAY CREATED BY HAVING TO RE-CUT THE BONE WITH CONVENTIONAL INSTRUMENTS.

  Patient problems: Insufficient Information

  MAUDE report 19228780 ↗
• MalfunctionMar 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PROCEEDED TO SECURE THE TRUMATCH JIG WITH OSTEOPHYTES STILL INTACT. OUTCOME WAS FEMORAL ROTATION WAS INTERNALLY ROTATED. CORONAL ALIGNMENT IS GOOD BUT HAD TO RECUT DISTAL FEMUR TO +4MM. ALSO, HAD DOWNSIZE FEMUR TO SIZE 7 INSTEAD OF 8. PROXIMAL TIBIAL NEEDED TO RECUT +2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 18911932 ↗
• MalfunctionDec 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE FLEXION AND EXTENSION GAPS WERE VERY, VERY NARROW AFTER THE INITIAL CUTS WERE DONE. SURGEON HAD TO RECUT THE UPPER TIBIA TWICE AND TAKE OUT AN ADDITIONAL 6MM, BEFORE HE COULD TRIAL THE SIZE 5 FEMUR, SIZE 4 TIBIAL IMPLANTS WITH A 8MM PS INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356072 ↗
• MalfunctionOct 6, 2023Scratched Material; Scratched Material

  FEMORAL IMPLANT WAS FLEXED 10-12 DEGREES. THE SURGEON BAILED ON FEMUR AND TIBIAL GUIDE. BLOCK HAD DEEP DISTAL FEMORAL CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885591 ↗
• MalfunctionOct 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SALES REP INDICATED THE PATIENT WAS PLANNED TO 2 DEGREES VALGUS ANGLE. THE SURGEON ENDED UP RESECTING FEMUR TO 6 DEGREES AND CUT AN ADDITIONAL 4MM OFF THE TIBIA. THE SALES REP INDICATED THE CASE WAS PLANNED TO PSA VERSE MECHANICAL ALIGNMENT. THE SALES REP INDICATED DUE TO PATIENTS LARGER SIZE IT IS UNUSUAL TO HAVE A CASE PLANNED TO 2 DEGREES VALGUS ANGLE. WHEN DRILLING FOR THE TIBIA THE SURGEON HIT THE POSTERIOR CORTEX. THE SURGEON ABANDONED THE FEMORAL GUIDE AND UTILIZED CONVENTIONAL INSTRUMENTATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17885568 ↗
• MalfunctionOct 6, 2023Incorrect Measurement; Patient-Device Incompatibility; Incorrect Measurement; Patient-Device Incompatibility

  IT WAS REPORTED THAT TIBIAL CUT WAS IN 10 OR 12 DEGREES (VARUS ANGLE). THE TRUMATCH CASE WAS PLANNED AT PERPENDICULAR TO MECHANICAL AXIS. NOTED THE CASE WAS PERFECT PSA ALIGNMENT. NO ADVERSE OUTCOME FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885518 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE TRUMACH TIBIA CUTTING GUIDE WHEN PASSING THE SAW. THE GUIDE SPLIT IN TWO. THERE WAS NO VISIBLE DEFECT BEFORE USE.THE TIBIAL CUTTING PROCEDURE WITH THE BROKEN TRUMACH WAS INTERRUPTED AT 3/4 OF THE PROCEDURE. THE SURGEON FINALIZED THE CUT FREEHAND USING THE LINE ALREADY DRAWN.HOWEVER, THERE WERE NO CONSEQUENCES FOR THE PATIENT, NO REMAINING DEBRIS OR CHANGES IN THE SLOPE OF THE CUT OR THE TIBIAL VARUS/VALGUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728060 ↗
• MalfunctionJul 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ONE OF THE PIN HOLES DID NOT FIT THE ATTUNE PINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379344 ↗
• MalfunctionJun 1, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT SPECIFIC PROXIMAL TIBIAL CUTTING JIG SPLIT DURING BONE RESECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043869 ↗
• MalfunctionFeb 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE METAL PIN HOLES WERE TOO NARROW FOR THE 3.2 PINS. TWO OF THE TRUMATCH BLOCKS HAVE SEEMED REALLY SNUG PUTTING PINS THROUGH. A COUPLE OF PINS WERE ALSO BROKEN OFF. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16449986 ↗
• MalfunctionFeb 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE METAL PIN HOLES WERE TOO NARROW FOR THE 3.2 PINS. TWO OF THE TRUMATCH BLOCKS HAVE SEEMED REALLY SNUG PUTTING PINS THROUGH. A COUPLE OF PINS WERE ALSO BROKEN OFF. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16445442 ↗
• MalfunctionFeb 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, HOW LONG? YES, 10 MINS WHILST THE SURGEON CONSIDERED THE SUGGESTED SIZE THEN SIZED THE FEMUR AND USED A FEMUR 3 SIZES SMALLER. B. WERE THERE ANY PATIENT CONSEQUENCES RELATED TO THE EVENT? SLIGHTLY LONGER ANESTHETIC THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311471 ↗
• MalfunctionApr 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIA RESECTION GUIDE WAS PLACED ON THE TIBIA AND PINNED TO THE BONE. THE MEDIAL FOOT WAS NOT CONTACTING THE PLATEAU SURFACE AND THE CUT WAS MADE. THIS RESULTED IN A HIGHER THAN EXPECTED TIBIA SLOPE, AN ESTIMATED 12 DEGREES PER SALES CONSULTANT. THE PLANNED POSTERIOR TIBIAL SLOPE WAS 3 DEGREES.

  Patient problems: Insufficient Information

  MAUDE report 14194292 ↗
• MalfunctionSep 24, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED, INDICATED THAT THERE WAS A 2-MINUTE DELAY. WHILE THEY CHECKED, THE PARTS WERE ALL ACCOUNTED FOR.

  Patient problems: Insufficient Information

  MAUDE report 12529053 ↗
• MalfunctionJun 9, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE TWO KNEES FROM WERE A BIT OVERLY, EXTERNALLY, ROTATED. THE SURGEON ENDED UP USING THE TRADITIONAL SIZER FOR 3 DEG ROTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967203 ↗
• MalfunctionMay 26, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED AS THAT THE KNEE WAS A BIT OVERLY, EXTERNALLY, ROTATED. SURGEON ENDED UP USING THE TRADITIONAL SIZER FOR 3 DEG ROTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888730 ↗
• MalfunctionJul 15, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED AS " EVENT DESCRIPTIONS: TMK23239 HAD TO RECUT FEMUR AND TIBIA 2MM TO GET A 5MM POLY IN. TMK23096 EXCESSIVE EXTERNAL ROTATION RESULTING IN TOO LARGE OF A POSTERIOR CONDYLE RESECTION. UNBALANCED. TMK23201 HAS TO RECUT TIBIA 2MM AND EXCESSIVE FEMORAL ROTATION RESULTING IN TOO LARGE OF A POSTERIOR CONDYLE RESECTION. UNBALANCED.

  Patient problems: Not Applicable

  MAUDE report 10278034 ↗
• MalfunctionJul 15, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED AS " EVENT DESCRIPTIONS: TMK23239 HAD TO RECUT FEMUR AND TIBIA 2MM TO GET A 5MM POLY IN. TMK23096 EXCESSIVE EXTERNAL ROTATION RESULTING IN TOO LARGE OF A POSTERIOR CONDYLE RESECTION. UNBALANCED. TMK23201 HAS TO RECUT TIBIA 2MM AND EXCESSIVE FEMORAL ROTATION RESULTING IN TOO LARGE OF A POSTERIOR CONDYLE RESECTION. UNBALANCED.

  Patient problems: Not Applicable

  MAUDE report 10278024 ↗
• MalfunctionFeb 6, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DISTAL FEMORAL RESECTION WAS FINE BUT WHEN THE SURGEON REPLACED THE DISTAL PINS THEY APPEARED TO BE IN A LOT OF EXTERNAL ROTATION. THE SURGEON ABORTED ON THE TRUMATCH AND USED THE ATTUNE TRADITIONAL SIZING GUIDE WHICH WAS 2 SIZES SMALLER THAN ON THE TRUMATCH PLAN. THEY THEN DECIDE TO JUST USE TRADITIONAL INSTRUMENTS ON THE PROXIMAL TIBIA RESECTION. THE SURGEON WAS VERY FRUSTRATED WITH TRUMATCH AND WONDERS IF SOMETHING IS WRONG WITH THE CT THAT SLVRMC IS PROVIDING DEPUY AND THIS IS WHY THE BLOCKS APPEAR TO BE SO OFF. AFTER CONVERTING BACK TO THE TRADITIONAL INSTRUMENTS THE REST OF THE CASE WENT FINE. MY APOLOGIES IF THIS IS DUPLICATED AS I LOST CONNECTION AND FELT I HAD TO START OVER. FYI OTHER THAN THE 5-MINUTE DELAY NO ADVERSE EVENTS TOOK PLACE TO THE PATIENT.

  Patient problems: Not Applicable

  MAUDE report 9676142 ↗
• MalfunctionJan 27, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PLAN FOR THE TRUMATCH DOES NOT MATCH WHAT THE ACTUAL BLOCK WERE RESECTION. IT WAS UNDER RESECTING SO THE SURGEON BAILED ON THE TRUMATCH AND WENT BACK TO THE TRADITIONAL ATTUNE INSTRUMENTS. NOTHING WAS BROKEN IT JUST DID NOT FUNCTION AS IT WAS INTENDED. A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9633328 ↗
• MalfunctionJan 17, 2020Break; Break

  IT WAS REPORTED THAT THE TRUMATCH TIBIAL CUTTING BLOCK PLASTIC WAS BROKEN DURING THE INITIAL PHASE OF CUTTING OF THE TIBIAL PLATEAU. THE TRUMATCH CUTTING BLOCK WAS REMOVED AND THE TRADITION ATTUNE TIB CUTTING BLOCK WAS PLACED TO GUIDE THE REMAINDER OF THE CUT. THE CASE WAS MAYBE DELAYED 1 MINUTE. NO ADDITIONAL ADVERSE EVENTS FOLLOWED AND THE CASE WENT ON SMOOTHLY.

  Patient problems: Not Applicable

  MAUDE report 9603816 ↗