BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XLA M/L SLEEVE 12/14 +2

    MDR report key: 2121349 · Received June 1, 2011

    Report

    Report Number
    1818910-2011-09184
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    May 5, 2011
    Manufacturer
    DEPUY INTL LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    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 HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XLA M/L SLEEVE 12/14 +2 87KWA KWA DEPUY INTL LTD. NA 2275054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention