TRUMATCH 420578Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295430797), received between Sep 9, 2019 and Mar 4, 2025 — classified as 7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2394-2021 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2025. CARTILAGE MODEL PREDICTED 2MM OF CARTILAGE ON THE MEDIAL PLATEAU OF THE PROXIMAL TIBIA. SALES REPRESENTATIVE STATED THAT THE MEDIAL FOOT OF THE PIN GUIDE WAS AIR BALLING AND THE PATIENT HAD NO CARTILAGE REMAINING ON MEDIAL SIDE. THEY ENDED UP RE-CUTTING THE TIBIA BY AN ADDITIONAL 4MM AND THE FEMUR BY 2MM. RELEASED PCL TO OPEN FLEXION GAP AND USED 5MM TIBIA POLY. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 21518309 ↗
• MalfunctionMar 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CARTILAGE MODEL PREDICTED 2MM OF CARTILAGE ON THE MEDIAL PLATEAU OF THE PROXIMAL TIBIA. THE SALES REP STATED THAT THE MEDIAL FOOT OF THE PIN GUIDE WAS AIRBALLING AND THE PATIENT HAD NO CARTILAGE REMAINING ON MEDIAL SIDE. THEY DISCOVERED A GOOD HOME FOR THE GUIDE DESPITE MEDIAL FOOT NOT CONTACTING. THE DOWN ROD WAS RUNNING INTO THE LEG WHEN CHECKING ALIGNMENT. AFTER PINNING, THE CUTTING BLOCK WAS PLACED AND DOWN ROD WAS CHECKED AGAIN, THE SLOPE AND ALIGNMENT APPEARED CORRECT. THEY MADE THE CUT AND SLOPE APPEARED CORRECT BUT WAS STILL TIGHT IN FLEXION, THEREFOR THE RECUT AND RELEASED PCL TO OPEN FLEXION GAP. IT WAS STATED THAT THE FEET OF THE GUIDE ARE SUPPOSED TO CONTACT THE PLATEAUS OF THE PROXIMAL TIBIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21503669 ↗
• MalfunctionApr 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED WHILE USING THE TRUMATCH PIN GUIDES WE WERE CONFRONTED WITH A CUTTING ACCURACY PROBLEM. FOR THE FEMORAL CUT, WE OBTAINED A DISTAL CUT APPROXIMATELY THREE TO FOUR MM LONGER THAN THE VALIDATED AND RECEIVED PLANNING. WE WERE CONFRONTED WITH A LOOSE EXTENSION GAP. WE HAD TO INCREASE THE PE THICKNESS DOWNSIZE THE FEMUR AND ANTERIORIZED THE CUTTING GUIDE. SURGERY DELAYED 20 MINUTES DUE TO THE REPORTED EVENT. ACTION TAKEN WHEN EVENT OCCURRED? --> WE USED THE CONVENTIONAL ATTUNE INSTRUMENTS, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211801 ↗
• MalfunctionApr 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED WHILE USING THE TRUMATCH PIN GUIDES WE WERE CONFRONTED WITH A CUTTING ACCURACY PROBLEM. FOR THE FEMORAL CUT, WE OBTAINED A DISTAL CUT APPROXIMATELY THREE TO FOUR MM LONGER THAN THE VALIDATED AND RECEIVED PLANNING. WE WERE CONFRONTED WITH A LOOSE EXTENSION GAP. WE HAD TO INCREASE THE PE THICKNESS DOWNSIZE THE FEMUR AND ANTERIORIZED THE CUTTING GUIDE. SURGERY DELAYED 20 MINUTES DUE TO THE REPORTED EVENT. ACTION TAKEN WHEN EVENT OCCURRED? --> WE USED THE CONVENTIONAL ATTUNE INSTRUMENTS, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211790 ↗
• MalfunctionOct 3, 2023Incorrect Measurement; Device-Device Incompatibility; Incorrect Measurement; Device-Device Incompatibility

  SURGEON INDICATED TIBIAL GUIDE DID NOT FIT WELL. THE PATIENT WAS LOOSE IN FLEXION AND THE SURGEON COULD NOT GET FLEXION GAP WELL BALANCED. (FIRST TIME TRUMATCH SURGEON). THE SALES REP STATED THE PATIENT HAD ATYPICAL ANATOMY THAT MAY HAVE CONTRIBUTED TO EVENT. THE SURGEON USED FEMUR GUIDE BUT ABANDONED TIBIAL GUIDE AND UTILIZED CONVENTIONAL INSTRUMENTATION TO COMPLETE THE CASE. THE SALES REP INDICATED NO ADVERSE EVENT OCCURRED FROM THE TRANSITION TO CONVENTIONAL INSTRUMENTATION. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY- UNKNOWN, (B)(4). DEVICE PROPERTY OF - NONE, DEVICE IN POSSESSION OF - NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.- TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860897 ↗
• MalfunctionDec 22, 2020Incorrect Measurement; Incorrect Measurement

  THE FOLLOWING PROBLEM OCCURRED DURING THE IMPLANTATION OF THE KNEE PROSTHESIS: AFTER CORRECT PLACEMENT OF THE FEMORAL TRUMACH TEMPLATE, THE FEMORAL RECEIVING SURFACE WAS FORMED. THE PROBE STOPPED AT 6 MM ON THE SUPRAPATELLAR SURFACE. BECAUSE OF THIS, WE HAD TO RESIZE, AND BY RESHAPING THE FEMORAL SURFACE, WE WERE ABLE TO GLUE 2 NUMBERS SMALLER PROSTHESES WITH SECURITY. IN THIS SIZE THE PROSTHESIS RESTED WELL BUT UNFORTUNATELY DUE TO THE SIZE REDUCTION THEY ALSO HAD TO ADJUST THE SIZE OF THE TIBIAL TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056043 ↗
• MalfunctionSep 9, 2019Incorrect Measurement; Incorrect Measurement

  TRUMATCH KNEE CASE TMK18936 HAD UNSATISFACTORY RESULTS. THE FEMUR WAS PLANNED 6 AND WE IMPLANT SIZE 4 AND THE TIBIA WAS PLANNED 5 AND WE IMPLANT SIZE 3. PRODUCT CODE: (B)(4). CASE NUMBER/LOT NUMBER: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8974491 ↗