BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO-MODEL SL

    MDR report key: 17641842 · Received August 29, 2023

    Report

    Report Number
    3004371426-2023-00085
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    September 16, 2021
    Report Date
    September 22, 2021
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    UDI-DI
    04026575359240
    PMA / PMN Number
    K151008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. THE REPORT IS DELAYED DUE TO ORIGINAL CLASSIFICATION OF THE CASE AS NON-REPORTABLE. DUE TO THE RECENT FDA INSPECTION WE REEVALUATED THE COMPLAINT IN COMPARISON TO SIMILAR COMPLAINTS WITH DIFFERENT OUTCOMES AND THEREFORE DETERMINED THAT IT IS REPORTABLE. WE HAVE ADDRESSED THIS OBSERVATION IN CAPA-23-08.

    Description of Event or Problem · 0

    ON 2021-09-21, DISTRIBUTOR WAS NOTIFIED THAT DURING AN SL HINGE KNEE REPLACEMENT ON (B)(6) 2021, A CONNECTION COMPONENT (PART # 16-2840/05, SN # (B)(6) PART DESCRIPTION: CONNECTION COMPONENT, ROTATIONAL VERSION, MEDIUM) DID NOT PROPERLY DEPLOY. THE SURGEON TRIED MULTIPLE TIMES TO GET THE LOCKING SCREW TO ENGAGE BUT WAS UNSUCCESSFUL. HOWEVER, A SECOND IDENTICAL DEVICE (PART # 16-2840/05, SN # (B)(6)) "WORKED PERFECTLY". AS PER THE SALES REPRESENTATIVE: "SURGERY TIME WAS ONLY EXTENDED BY A FEW MINUTES. JUST LONG ENOUGH FOR US TO GO THE STORAGE ROOM AND GET ANOTHER MEDIUM CONNECTION COMPONENT. THE CASE ENDED UP GREAT". THE COMPLAINT SAMPLE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE "IT FELL INTO FOUR OR FIVE SEPARATE PIECES WHEN IT FAILED AND WAS THROWN AWAY LATER". [CUSTOMER].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057778 ENDO-MODEL SL CONNECTION COMPONENT, INCL. TIBIAL PLATEAU, UNCEMENTED, COCRMO, UHMWPE, ROTATING KRO WALDEMAR LINK GMBH & CO. KG 16-2840/05 04026575359240

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown