BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EF1

    MDR report key: 21931581 · Received April 29, 2025

    Report

    Report Number
    3007593722-2025-00005
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    March 1, 2025
    Report Date
    August 6, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    KTT
    UDI-DI
    00810028397101
    PMA / PMN Number
    K151580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN EF1 CASE SHOWING SOME OF THE UNIVERSAL JOINTS DISCONNECTED. FOLLOW UP WITH CONFIRMED NO PATIENT HARM RELATED TO THE COMPLAINT. INITIALLY, IT WAS PRESUMED THE UNIVERSAL JOINT FAILURE WAS DUE TO NON-COMPLIANCE OF THE PATIENT BEING WEIGHT BEARING PREMATURELY. HOWEVER, IN RESPONSE TO THIS AND ADDITIONAL SIMILAR COMPLAINTS, A CROSS-FUNCTIONAL MEETING WAS HELD ON (B)(6) 2025 TO FURTHER DISCUSS THE UNIVERSAL JOINT DISCONNECTION ISSUE. DURING THAT MEETING, THE INVESTIGATION TEAM IDENTIFIED A SUBSET OF THE UNIVERSAL JOINT POPULATION THAT CAN HAVE A SITUATION IN WHICH THE SHORT PINS WHICH ARE PRESS FIT TO HOLD THE UNIVERSAL JOINT TOGETHER CAN BECOME LOOSE AND DISLODGE. IN THIS SUBSET THE UNIVERSAL JOINTS CAN BECOME DISCONNECTED. FOR THE PURPOSE OF MDR REPORTING, THE (B)(6) 2025 MEETING SERVES AS AWARENESS THIS COMPLAINT WAS MORE ASSOCIATED WITH A COMPONENT ISSUE AND LESS ASSOCIATED WITH PATIENT NON-COMPLIANCE. AS AN OUTCOME FROM THE MEETING, A HEALTH HAZARD EVALUATION WAS INITIATED TO ASSESS PATIENT IMPACT AND THE DECISION WAS MADE TO OPEN A CAPA TO DOCUMENT AND FURTHER INVESTIGATE THE CAUSE AND IDENTIFY CORRECTIVE ACTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT: DEVICE BROKE POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757336 EF1 UNIVERSAL JOINTS KTT MEDSHAPE, INC. UNKNOWN 00810028397101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other