BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR TAP SLV ADAP 12/14 -1

    MDR report key: 3211706 · Received July 8, 2013

    Report

    Report Number
    1818910-2013-20667
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    February 28, 2013
    Report Date
    June 10, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK070359
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    LITIGATION PAPERS ALLEGE PAIN AND DISCOMFORT IN HIS HIP AND GROIN AREA, LIMITATION IN HIS RANGE OF MOTION, DIFFICULTY IN BENDING AND OTHER SYMPTOMS AND OTHER COMPLICATIONS. PATIENT'S REVISION OPERATIVE REPORT WAS RECEIVED. UPON REVISION THE CUP WAS FOUND TO HAVE NO BONE INGROWTH, AND CORROSION WAS FOUND AROUND THE STEM. THE SLEEVE AND STEM ARE BEING ADDED TO THE COMPLAINT RE-OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308627 ASR TAP SLV ADAP 12/14 -1 SLEEVE KWA DEPUY INTL., LTD. - 8010379 2732527

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR