BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 2162206 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12496
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    DEPUY FRANCE S. A.
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).

    Description of Event or Problem · 1

    THE PT IS SCHEDULED FOR AN ASR REVISION TO ADDRESS PAIN ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE 12 87KWA, LZO, MEH, LWJ KWA DEPUY FRANCE S. A. NA 2384384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention