BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S- ROM SLEEVE PRX ZTT, 18B-SML

    MDR report key: 1954311 · Received January 5, 2011

    Report

    Report Number
    1818910-2011-00068
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K934412
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS FEMORAL LOOSENING. IT WAS REPORTED THAT THE STEM MAY POSSIBLY HAVE BEEN UNDERSIZED WHEN ORIGINALLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S- ROM SLEEVE PRX ZTT, 18B-SML 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention