TRUMATCH 420915Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295384854), received between Jul 11, 2019 and Jun 6, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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-2398-2021 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE TRUMATCH TODAY FOR THE FIRST TIME. DURING INSERTION, THE DISTAL FEMUR GUIDE WAS DIFFICULT TO FULLY APPLY. THE PLANNING GAVE A SIZE 6 FEMUR, BUT SURGEON USED A FEMORAL SIZER FROM THE ANCILLARY BECAUSE THE ROTATION GIVEN SEEMED COMPLETELY INCORRECT, AS DID THE SIZING. AGREED ON A SIZE 4 FOR THE FEMUR. THIS IS STILL A BIG DIFFERENCE FROM SIZE 6. FOR THE TIBIA, SURGEON ALSO HAD TO SWITCH TO A SIZE 4 INSTEAD OF THE 5 PLANNED IN THE PLANNING. SURGEON DIDN'T MAKE ANY LARGE CUTS AND HAD TO RE-CUT THE DISTAL FEMUR BECAUSE THE EXTENSION SPACE WAS TOO TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157384 ↗
• MalfunctionDec 13, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: "THE COMPLAINT RELATES TO THE TIBIAL CUTTING BLOCK. IT WAS ON THE TIBIAL GUIDE JUST ABOVE THE METAL CUTTING SLOT WHICH CAME AWAY FROM THE BLOCK. I BELIEVE HE WAS USING QUITE A STANDARD CUTTING BLADE, NOT SURE OF EXACT DETAILS THOUGH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20928755 ↗
• MalfunctionNov 5, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : CUSTOMER "USED A WIDER SAW BLADE FOR THIS PATIENT DUE TO LARGER PATIENT ANATOMY VERSUS USING THE RECOMMENDED WHALE TAIL BLADE. HE WAS STILL ABLE TO COMPLETE THE RESECTIONS WITHOUT ANY SURGICAL DELAY AND WAS PLEASED WITH PATIENT OUTCOME". "HE IS AWARE TO USE WHALE TALE BLADE FOR FUTURE TMK CASES".

  Patient problems: Insufficient Information

  MAUDE report 20609993 ↗
• 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. THE DEVICE SEEMED TO UNDERCUT 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 19228829 ↗
• 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 19228768 ↗
• MalfunctionJan 22, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. STATING, THAT THERE WAS NO SURGICAL DELAY OR ANY ADVERSE OUTCOME THAT OCCURRED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553768 ↗
• MalfunctionJan 19, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE METAL CUTTING SLOT ON THE FEMORAL TRUMATCH GUIDE HAS BEEN BACKING OUT AS IT WAS CUT THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547661 ↗
• MalfunctionNov 16, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT POST OP X-RAYS INDICATE PATIENT OUTCOME RESULTED IN 27 DEGREES OF FLEXION. SURGEON IS DISSATISFIED WITH THE RESULT OF THE PLANNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155405 ↗
• MalfunctionOct 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  SALES REP INDICATED THE PLAN WAS MORE IN LINE WITH PSA VERSE MECHANICAL ALIGNMENT. THE CASE WAS PLANNED AT 4 DEGREES VALGUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885673 ↗
• MalfunctionMay 16, 2023Incorrect Measurement; Device-Device Incompatibility; Incorrect Measurement; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FEMORAL JIG WHERE THE LATERAL DISTAL PIN HOLE WAS A FRACTION TOO SMALL FOR THE PIN TO GO THROUGH. BY REMOVING THE JIG FROM THE PATIENT AND DRILLING A PIN VERY FIRMLY THROUGH THE HOLE, EVENTUALLY COULD PASS A PIN. THE FIRST PIN WAS SIGNIFICANTLY ABRADED IN THE PROCESS OF WIDENING THE HOLE. THE SECOND ISSUE WAS THAT THE TEMPLATING PROCESS HAD SUGGESTED A SIZE 5N FEMUR AND A SIZE 5 TIBIA. WHEN THE SIZE 5 BLOCK WAS APPLIED AND THE ¿ANGEL WING¿ USED TO CHECK WHERE THE CUT WOULD TAKE PLACE IS WAS CLEAR THAT ONLY A VERY TINY ANTERIOR SLICE WOULD BE REMOVED AND TRYING A SIZE 4 BLOCK PROVIDED A BETTER FIT. ON THE TIBIAL SIDE THE CUT WAS FINE BUT THE SIZE WAS A BETTER FIT WITH A SIZE 4 IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937818 ↗
• MalfunctionMar 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? -1 MINUTE TO ADJUST THE GUIDE. B. WAS THERE ANY IMPACT ON THE PATIENT? IF YES, PLEASE CLARIFY IN DETAIL. -NO PT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551639 ↗
• MalfunctionMar 11, 2022Incorrect Measurement; Patient-Device Incompatibility; Incorrect Measurement; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE AFTER CUTTING TIBIA THE SLOPE WAS 14 DEGREES INSTEAD OF THE PLANNED 3 DEGREES. PATIENT¿S NATURAL TIBIA SLOPE ON THE PLAN WAS 17 DEGREES. SURGEON DID NOT USE RECOMMENDED 1.19MM WHALE TAIL.

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

  MAUDE report 13732918 ↗
• 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 10278007 ↗
• MalfunctionOct 25, 2019Incorrect Measurement; Incorrect Measurement

  THE GUIDES POST OP IMAGES SEEM TO HAVE PUT THE TIBIAL CUTS INTO VARUS, AS THIS SEEMED TO BE CONSISTENT CHALLENGE HE WANTED TO FEEDBACK. WONDERED IF COULD BE ANY LEARNINGS AS STRANGE FOR ALL TO BE FOLLOWING SAME PATTERN AND HE FEEDS BACK THAT HE FELT THE TIBIAL GUIDE FIT WAS SOLID ON EACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239590 ↗
• MalfunctionAug 14, 2019Incorrect Measurement; Incorrect Measurement

  OVERALL THE END RESULT WAS GOOD WITH THE EXCEPTION OF THE TIBIA SLOPE. THE GUIDE FIT WELL INTRAOPERATIVELY THOUGH THE RESULTING CUT APPEARED TO HAVE NO SLOPE/ANTERIOR SLOPE WHILE THE PLAN CALLED FOR 3 DEGREES OF POSTERIOR SLOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893418 ↗
• MalfunctionJul 11, 2019Incorrect Measurement; Incorrect Measurement

  TRUMATCH GUIDE FIT WELL BUT APPEARED TO BE SHIFTED MEDIALLY FROM WHAT THEY TYPICALLY SEE FOR THE GUIDES. ADDITIONALLY, NOTICED CRACKING ON THE LATERAL LEG OF THE TIBIA RESECTION GUIDE NEAR THE AREA OF THE IMPRINTED ALIGNMENT LINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780749 ↗