BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC CEM STEM 10/12 SZ 1M

    MDR report key: 1152861 · Received September 5, 2008

    Report

    Report Number
    1818910-2008-03829
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    DEPUY-CORK, A DIVISON OF DEPUY ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    K953202
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 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

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING OF THE HIP STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC CEM STEM 10/12 SZ 1M 87JDI JDI DEPUY-CORK, A DIVISON OF DEPUY ORTHOPAEDICS NA 1058272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention