BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MK TRIAL FEMORAL SPACER DISTAL LL/RM 4/5MM

    MDR report key: 24077723 · Received January 15, 2026

    Report

    Report Number
    3012523063-2026-00003
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 12, 2025
    Report Date
    March 6, 2026
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, THE FIXATION PIN OF A FEMORAL TRIAL SPACER BROKE OFF DURING SURGERY. THE FIXATION PIN IS SUPPOSED TO CONNECT THE FEMORAL TRIAL SPACER TO THE FEMORAL TRIAL COMPONENT DURING TRIAL POSITIONING PRIOR TO IMPLANTATION. THE SURGERY WAS COMPLETED USING THE AFFECTED PRODUCT. IT WAS REPORTED THAT THE EVENT DID NOT HAVE ANY HEALTH IMPACT ON THE PATIENT, USERS OR THIRD PARTIES. THE PRODUCT IN QUESTION WAS NOT SENT BACK TO IMPLANTCAST GMBH, THUS, NO OPTICAL EXAMINATION COULD BE PERFORMED. THE MANUFACTURING DOCUMENTS AND MATERIAL CERTIFICATES OF THE FEMORAL TRIAL SPACER WERE CHECKED AND DID NOT SHOW ANY ERRORS. BASED ON THE AVAILABLE INFORMATION, NO FAILURE OF THE DESIGN OR DURING THE MANUFACTURING PROCESS COULD BE DETERMINED. THE PRODUCT IS MADE OF POLYPROPYLENE AND WAS IN USE FOR MORE THAN SIX YEARS. IT CAN ONLY BE ASSUMED THAT REPEATED USE AS INTENDED AND TEMPERATURE FLUCTUATIONS IN MULTIPLE STERILIZATION CYCLES LEAD TO WEAKENING OF THE MATERIAL, BEFORE IT ULTIMATELY FRACTURED. HOWEVER, THIS CAN NEITHER BE CONFIRMED NOR DENIED DUE TO LACK OF INFORMATION. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, THE FIXATION PIN OF A FEMORAL TRIAL SPACER BROKE OFF DURING SURGERY. THE FIXATION PIN IS SUPPOSED TO CONNECT THE FEMORAL TRIAL SPACER TO THE FEMORAL TRIAL COMPONENT DURING TRIAL POSITIONING PRIOR TO IMPLANTATION. THE SURGERY WAS COMPLETED USING THE AFFECTED PRODUCT. IT WAS REPORTED THAT THE EVENT DID NOT HAVE ANY HEALTH IMPACT ON THE PATIENT, USERS OR THIRD PARTIES. IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON 02/19/2026. THE OPTICAL EXAMINATION REVEALED THAT THE REPORTED PIN HAS BROKEN OFF. THE MANUFACTURING DOCUMENTS AND MATERIAL CERTIFICATES OF THE FEMORAL TRIAL SPACER WERE CHECKED AND DID NOT SHOW ANY ERRORS. BASED ON THE AVAILABLE INFORMATION, NO FAILURE OF THE DESIGN OR DURING THE MANUFACTURING PROCESS COULD BE DETERMINED. THE PRODUCT IS MADE OF POLYPROPYLENE AND WAS IN USE FOR MORE THAN SIX YEARS. IT CAN ONLY BE ASSUMED THAT REPEATED USE AS INTENDED AND TEMPERATURE FLUCTUATIONS IN MULTIPLE STERILIZATION CYCLES LEAD TO WEAKENING OF THE MATERIAL, BEFORE IT ULTIMATELY FRACTURED. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE FEMORAL SPACER DID NOT HOLD DURING THE OPERATION; BOTH PINS BROKE OFF. THE SPACER WAS THEN USED WITHOUT FIXATION. THIS DID NOT CAUSE ANY PROBLEMS DURING THE OPERATION OR HAVE ANY IMPACT ON THE PATIENT. "

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE FEMORAL SPACER DID NOT HOLD DURING THE OPERATION; BOTH PINS BROKE OFF. THE SPACER WAS THEN USED WITHOUT FIXATION. THIS DID NOT CAUSE ANY PROBLEMS DURING THE OPERATION OR HAVE ANY IMPACT ON THE PATIENT. " FOLLOW-UP: IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON 02/19/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140386 MK TRIAL FEMORAL SPACER DISTAL LL/RM 4/5MM TRIAL SPACER HWT IMPLANTCAST GMBH 77244005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other