BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN 100 W/GRIPTION 50MM

    MDR report key: 2973693 · Received February 22, 2013

    Report

    Report Number
    1818910-2013-12722
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 22, 2012
    Report Date
    October 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK090998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2013 - LITIGATION AND PFS WITH MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. IT IS ALLEGED THAT THE PATIENT SUFFERED FROM DISLOCATION INFECTION, AND LOOSENING; HOWEVER, MEDICAL RECORDS INDICATE THE REASON FOR REVISION WAS INSTABILITY. THEREFORE, NOT ALL PRODUCTS WILL BE REPORTED AT THIS TIME. REVISION OPERATIVE NOTES ALSO MENTION THAT THE CUP WAS "VERTICAL AND IN A NEUTRAL POSITION." THE UNKNOWN DEVICE HAS BEEN UPDATED TO A CUP. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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 ALLEGES THAT THE PATIENT SUFFERS PAIN, LACK OF MOBILITY, METALLOSIS, AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77688 PINN 100 W/GRIPTION 50MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US E98HW1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention