BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM SLEEVE PRX ZTT, 16F-LRG

    MDR report key: 1222496 · Received November 5, 2008

    Report

    Report Number
    1818910-2008-05132
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A LOOSE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM SLEEVE PRX ZTT, 16F-LRG 87MRA MRA DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 1059489

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention