BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 2823051 · Received November 7, 2012

    Report

    Report Number
    1818910-2012-27426
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    July 25, 2012
    Report Date
    October 29, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND METALLOSIS. (B)(6) 2012 - PATIENTS OPERATIVE NOTES WERE RECEIVED. IT WAS NOTED THE PATIENT HAD MILD CORROSION AT THE TRUNNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER SLEEVES 12/14 +2 ADAPTER SLEEVE KWA DEPUY INTERNATIONAL 2486028

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR