BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINKSYMPHOKNEE

    MDR report key: 17041680 · Received June 1, 2023

    Report

    Report Number
    3004371426-2023-00040
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    December 1, 2022
    Report Date
    January 10, 2023
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    HRY
    UDI-DI
    04026575255948
    PMA / PMN Number
    K202924
    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 RE-EVALUATED 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

    THE SPACER DID NOT APPEAR TO SEAT PROPERLY SO DR. N. EX-PLANTED THE POLY SPACER AND OPENED A NEW SPACER TO IMPLANT. THE SECOND POLY SEEMED TO SEAT WITHOUT ISSUE.[CUSTOMER].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30700 LINKSYMPHOKNEE ARTICULATING SURFACE, SYMMETRIC, SZ. 5-6 X-LINKED VIT-E P , PS, FIXED, H= 10 MM HRY WALDEMAR LINK GMBH & CO. KG 880-255/10 2214023 04026575255948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown