BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARSTEM

    MDR report key: 3050255 · Received April 10, 2013

    Report

    Report Number
    9613369-2013-00030
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SMITH&NEPHEW - SWITZERLAND
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149931 POLARSTEM POLARSTEM STEM STD WITH TI/HA 4 NON-CEM KWZ SMITH&NEPHEW - SWITZERLAND B1018256

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R PART NO: UNK -ANA NOVA CUP SIZE 56 - LOT NO: UNK| PART NO: UNK -CE INSERT 36MM - LOT NO: UNK| PART NO: UNK -CE BALL HEAD SIZE 36M, - LOT NO: UNK