BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILELINK ACETABULAR CUP SYSTEM

    MDR report key: 19989992 · Received August 15, 2024

    Report

    Report Number
    3004371426-2024-00055
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    May 21, 2024
    Report Date
    July 22, 2024
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    LPH
    UDI-DI
    04026575175475
    PMA / PMN Number
    K182321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE QUALITY DATA ANALYSIS (QDA DATA) SHOWED NO DEVIATIONS. THIS IS THE FINAL SUPPLEMENTAL REPORT, THE COMPLAINT IS CLOSED.

    Description of Event or Problem · 0

    DURING TOTAL HIP REPLACEMENT SURGERY, ONE SCREW OF THE 46MM MOBILELINK ACETABULAR CUP COULD NOT BE REMOVED, RESULTING IN A MODIFIED SURGICAL PROCEDURE.

    Description of Event or Problem · 0

    DURING TOTAL HIP REPLACEMENT SURGERY, ONE SCREW OF THE 46MM MOBILELINK ACETABULAR CUP COULD NOT BE REMOVED, RESULTING IN A MODIFIED SURGICAL PROCEDURE. [CUSTOMER].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095305 MOBILELINK ACETABULAR CUP SYSTEM SHELL, CLUSTER HOLE, UNCEMENTED, TICAP, O.D.= 46MM, FOR INSERT SIZE B, TILASTAN- LPH WALDEMAR LINK GMBH & CO. KG 183-101/46 04026575175475

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female