BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 2942988 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-02154
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    .

    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. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATE - (B)(4) 2012 PATIENT FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED LOT INFORMATION. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO ALVAL AND CORROSION OF TRUNNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48453 ADAPTER SLEEVES 12/14 +2 SLEEVE KWA DEPUY INTERNATIONAL 2643403

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention