BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASYSTEM C

    MDR report key: 17369330 · Received July 21, 2023

    Report

    Report Number
    3004371426-2023-00054
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    WALDEMAR LINK GMBH&CO.KG
    Product Code
    KRO
    UDI-DI
    04026575381753
    PMA / PMN Number
    K143179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS IS THE FINAL SUPPLEMENTAL REPORT, THE COMPLAINT IS CLOSED.

    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.

    Description of Event or Problem · 0

    DURING SURGERY LAST WEEK, THE SURGEON WANTED TO USE IMPLANT 15-8521/10 LOT 200113/1159 07/25 BUT WAS UNPLEASANTLY SURPRISED TO FIND THAT THE STERILE BAG HAD BEEN PUNCTURED. THE CARDBOARD PACKAGING OF THE IMPLANT WAS NOT DAMAGED.

    Description of Event or Problem · 0

    DURING SURGERY LAST WEEK, THE SURGEON WANTED TO USE IMPLANT 15-8521/10 LOT 200113/1159 07/25 BUT WAS UNPLEASANTLY SURPRISED TO FIND THAT THE STERILE BAG HAD BEEN PUNCTURED. THE CARDBOARD PACKAGING OF THE IMPLANT WAS NOT DAMAGED. [CUSTOMER].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146963 MEGASYSTEM C FEMORAL COMPONENTS,CONDYLAR REPLACEMENTLINK MEGASYSTEM-C,MEDIUM, RIGHT KRO WALDEMAR LINK GMBH&CO.KG 15-8521/10 04026575381753

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown