BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTHOLOGY SO POROUS SZ 11

    MDR report key: 7206776 · Received January 19, 2018

    Report

    Report Number
    1020279-2018-00069
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    January 15, 2018
    Report Date
    April 5, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDI
    UDI-DI
    03596010567819
    PMA / PMN Number
    K052792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR REFERENCE NO. 1020279-2018-00069/1020279-2018-00070/1020279-2018-00090. DEAR LADIES AND GENTLEMEN, FOLLOWING RECEIPT OF ADDITIONAL INFORMATION CONCERNING THIS CASE, IT HAS BEEN DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR. PLEASE THEREFORE DISREGARD THIS REPORT. THIS ISSUE WAS ALREADY REPORTED UNDER 1020279-2018-00074. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49557 ANTHOLOGY SO POROUS SZ 11 PRSTHSS,HIP,SMCNSTRND,MTLPLYMR,CMENTD JDI SMITH & NEPHEW, INC. 08MM19230 03596010567819

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R