BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR TAP SLV ADAP 12/14 -1

    MDR report key: 2874746 · Received December 16, 2012

    Report

    Report Number
    1818910-2012-28462
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Date of Event
    September 25, 2012
    Report Date
    November 27, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K070359
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    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). 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 OSTEOLYTIC CHANGES BEHIND THE CUP AND INTO THE GREATER TROCHANTER. DOI: APPROX. 5 YEARS AGO. DOR: (B)(6) 2012 (RIGHT HIP). (B)(4) 2012 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED DUE TO INCREASING PAIN. NOTED WAS METALLOSIS AND CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR TAP SLV ADAP 12/14 -1 ADAPTOR SLEEVE KWA DEPUY INTERNATIONAL 2745984

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR