BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2211798 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-15400
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    April 16, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: BRAND NAME, COMMON DEVICE NAME/DEVICE PRODUCT CODE, CATALOG #/LOT #, 510K, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PT WAS IMPLANTED WITH DEPUY ASR HIP ON HIS RIGHT SIDE ON (B)(6), 2007. PT HAS SUFFERED SIGNIFICANT DISCOMFORT, PAIN, STIFFNESS AND, UPON INFO AND BELIEF, LOOSENING OF THE HIP, ALL OF WHICH RESULTS IN DIFFICULT AND PAINFUL MOBILITY AND AMBULATION. PT WILL HAVE TO UNDERGO REVISION SURGERY.

    Description of Event or Problem · 1

    **UPDATE**(B)(6) 2013 - SALES REP REPORTED REVISION SURGERY ON RIGHT HIP DUE TO PAIN. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 ACETABULAR SHELL KWA DEPUY INTERNATIONAL, LTD. NA 2409583

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention