BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SLEEVE 11/13 +0

    MDR report key: 2801194 · Received October 23, 2012

    Report

    Report Number
    1818910-2012-22652
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    November 16, 2010
    Report Date
    October 1, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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. UPDATE: (B)(6) 2012 - REVISION OPERATIVE REPORT WAS RECEIVED. THE PATIENT WAS REVISED TO ADDRESS PAIN, CYST, CORROSION NOTED AT THE HEAD-STEM TAPER JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER SLEEVE 11/13 +0 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2557005

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR