BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL STEM K9S HAC

    MDR report key: 2397367 · Received January 4, 2012

    Report

    Report Number
    1818910-2012-00400
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    November 21, 2011
    Report Date
    December 8, 2011
    Manufacturer
    DEPUY FRANCE
    Product Code
    LZO
    PMA / PMN Number
    K953111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    FURTHER ANALYSIS COULD NOT BE CARRIED OUT BECAUSE, NO SUFFICIENT INFORMATION WAS RETRIEVED: THE PRODUCT WAS NOT RETURNED TO DEPUY FRANCE, THE PRODUCT REFERENCE COULD NOT BE VERIFIED AND THE LOT NUMBER COULD NOT BE IDENTIFIED. THE ANALYSIS CONFIRMED THE DISTAL FRACTURE OF THE STEM. IT COULD NOT HOWEVER EXPLAIN THE CAUSE OF THE FRACTURE. NO FURTHER ANALYSIS WAS POSSIBLE (NO PRODUCT RETURN, NO BATCH NUMBER). 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.

    Description of Event or Problem · 1

    FRACTURE OF A CORAIL STEM K9S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL STEM K9S HAC HIP STEM LZO DEPUY FRANCE ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1