BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML 18.0 STD 6.3 5/8 STD 12/14

    MDR report key: 1233624 · Received November 14, 2008

    Report

    Report Number
    1818910-2008-05193
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K953694
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 KNOWN PRODUCT AND LOT CODE 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 THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADD'L INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PT REVISED FOR PAIN. INTRAOPERATIVELY STEM WAS SLIGHTLY VARUS AND VERY WELL FIXED; POLYETHYLENE WEAR NOTED ON LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML 18.0 STD 6.3 5/8 STD 12/14 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA RG1HS1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention