BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML MMA 13.5MM 6.3 IN STEM

    MDR report key: 1294918 · Received January 22, 2009

    Report

    Report Number
    1818910-2009-00128
    Event Type
    Injury
    Date Received
    January 22, 2009
    Date of Event
    January 6, 2009
    Report Date
    January 6, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LZO
    PMA / PMN Number
    K941847
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE ITS 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML MMA 13.5MM 6.3 IN STEM 87LZO LZO DEPUY ORTHOPAEDICS, INC. NA 843270

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention