BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYN TRIAL NECK SZ 8-13

    MDR report key: 13624813 · Received February 28, 2022

    Report

    Report Number
    1020279-2022-00905
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 8, 2022
    Report Date
    March 15, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    UDI-DI
    03596010199898
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: FURTHER REVIEW OF THIS CASE INDICATES THIS IS A DUPLICATE REPORT. THE EVENT IN THIS REPORT HAS BEEN ALREADY REPORTED UNDER MDR NO. 1020279-2022-00910. ALL FURTHER COMMUNICATION FOR THIS EVENT WILL BE MANAGED IN THAT CASE, INCLUDING A FOLLOW UP REPORT WITH THE RESULTS OF OUR INVESTIGATION. WE RESPECTFULLY REQUEST TO CLOSE THE CASE AS A DUPLICATE AND REFER TO THE REFERENCED CASE ABOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE MAGNET OF A SYN TRIAL NECK SZ 8-13 APPEARS TO BE PEELING AWAY. AS THIS WAS NOTICED IN A NO-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298213 SYN TRIAL NECK SZ 8-13 PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW, INC. 71366408 70904005 03596010199898

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown