BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 2945550 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-02083
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    August 29, 2011
    Report Date
    January 31, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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). 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 DUE TO PAIN. IT WAS NOTED THAT THE CUP WAS WELL FIXED. THE REVISION OPERATIVE REPORT INDICATES THAT THE SURGEON FELT THAT THE FAILURE WAS AT THE TRUNION. IT WAS NOTED THAT THIS WAS THE ONLY PLACE WHERE METALLOSIS WAS OBSERVED. THE HEAD AND SLEEVE WERE EXCHANGED ON (B)(6) 2009. REASON FOR EXCHANGE IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50924 ADAPTER SLEEVES 12/14 +5 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 3002977

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention