BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMA FEM STEM, M SERIES, SZ2M

    MDR report key: 1002215 · Received February 21, 2008

    Report

    Report Number
    1818910-2008-00600
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWL
    PMA / PMN Number
    K900638
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION 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 ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS STEM LOOSENING, INTEROPERATIVELY FOUND 3RD BODY WEAR ON ACETABULUM FROM UNK MANUFACTURED CEMENT PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA FEM STEM, M SERIES, SZ2M 87KWL KWL DEPUY ORTHOPAEDICS, INC. NA 1160477

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention