BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ASR FEM IMP SIZE 51

    MDR report key: 2023410 · Received March 2, 2011

    Report

    Report Number
    1818910-2011-02675
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 24, 2011
    Report Date
    January 31, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    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).

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    THE PT HAS BEEN RECOMMENDED FOR AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 51 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2628744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention