BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL STEM KAR14 HAC

    MDR report key: 3063481 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15478
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    3003895575 DEPUY FRANCE
    Product Code
    LZO
    PMA / PMN Number
    PK961732
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DHR ANALYSIS (FOR PRODUCT CODE L92524) THE DHR ANALYSIS OF THE BATCH RETURNED (5107729) SHOWS AN INITIAL CONFORMANCE OF THIS PRODUCT WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR FAILURE INVESTIGATION REPORT. X-RAY ANALYSIS: THIS ANALYSIS WAS PERFORMED BY DEPUY FRANCE BIOENGINEER: IT WAS CONCLUDED THAT AS THE SURGEON INDICATED (COMMENTS INCLUDED IN THE COMPLAINT DESCRIPTION), THE KAR STEM MAY NOT HAVE BEEN THE MOST APPROPRIATE IMPLANT FOR SUCH REVISION CASE. THE SUBSIDENCE OF THE STEM CAN EXPLAIN THE LACK OF OSSEOINTEGRATION AND THE PRESENCE OF THE HA COATING ON THE STEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. NO OTHER ANALYSIS WAS POSSIBLE BECAUSE THE PRODUCTS WERE NOT RETURNED

    Description of Event or Problem · 1

    THE STEM HAD SUBSIDED AND SO WAS REVISED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164673 CORAIL STEM KAR14 HAC HIP STEM LZO 3003895575 DEPUY FRANCE 5107729

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention