BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILELINK ACETABULAR CUP SYSTEM

    MDR report key: 17335124 · Received July 17, 2023

    Report

    Report Number
    3004371426-2023-00059
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    July 4, 2023
    Report Date
    July 4, 2023
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    OQG
    UDI-DI
    04026575182329
    PMA / PMN Number
    K200607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS CHECKED AND THE OFFSET OF THE LABEL DOES NOT CONFIRM TO THE SPECIFICATION. IT HAS COME TO OUR ATTENTION THAT THE OFFSET ON THE LABELS OF THE SHELL/INSERT ADAPTER DOES NOT MATCH TO THE ARTICLE REF AND THE DESCRIPTION IN THE SURGICAL TECHNIQUE. THIS ONLY AFFECTS THE ARTICLE REF 183-610/05. FOR THESE PRODUCTS IT SHOULD BE +12 MM OFFSET ON ALL LABELS INCLUDING THE LABEL FOR THE IMPLANT CARD, BUT THE SHELL/INSERT ADAPTER WERE INCORRECTLY LABELLED AS + 8 MM OFFSET. THE PRODUCT IN THE PACKAGING HAS A +12 MM OFFSET, WHICH IS CORRECT AND FITS TO THE ARTICLE REF AND THE DESCRIPTION OF THE SURGICAL TECHNIQUE. WALDEMAR LINK GMBH & CO. KG IS THEREFORE PROVIDING A SAFETY INFORMATION AND RECALLING THE AFFECTED ITEMS FROM THE MARKET: R-2023-08.

    Description of Event or Problem · 0

    PLEASE SEE ATTACHED COMPLAINT RE LABELLING ISSUE WITH MOBILELINK LINER 183-610/05, ALSO BELOW IMAGE SHOWS THE LABEL STATES +8MM RATHER THAN +12MM AS SHOULD BE. THE REPRESENTATIVE NOTICED THE DISCREPANCY IN THE LABELING WHEN CHECKING CUSTOMER'S INVENTORY. [CUSTOMER].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664453 MOBILELINK ACETABULAR CUP SYSTEM SHELL/INSERT ADAPTER FOR SHELL 74-80 MM, INSERT SIZE F, + 12 MM OFFSET OQG WALDEMAR LINK GMBH & CO. KG 183-610/05 04026575182329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown