BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL STEM KAR16 HAC

    MDR report key: 3141365 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-17744
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 23, 2013
    Manufacturer
    3003895575 DEPUY FRANCE
    Product Code
    LZO
    PMA / PMN Number
    PK961732
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR ANALYSIS: THE DHR ANALYSIS OF THE BATCH RETURNED SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR FAILURE INVESTIGATION REPORT. NO OTHER ANALYSIS WAS POSSIBLE BECAUSE NO PRODUCT/ X-RAYS WERE RETURNED THE ROOT CAUSE IS UNDETERMINED BASED ON THE ABOVE ELEMENTS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WE CLOSE THIS COMPLAINT AS UNDETERMINED AND WILL RE-OPEN IT IF ANY RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    REVISION OF KAR STEM TO A REEF DUE TO MALPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244231 CORAIL STEM KAR16 HAC HIP STEM LZO 3003895575 DEPUY FRANCE 5202148

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR