BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN 100 W/GRIPTION 52MM

    MDR report key: 3202620 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20410
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK090998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS STILL UNDER INVESTIGATION. 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 COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. WITH THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE IMPLANTS CONTRIBUTED TO THE REPORTED EVENTS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. IT IS ALLEGED THAT THE PATIENT WAS IMPLANTED WITH PINNACLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301269 PINN 100 W/GRIPTION 52MM ACETABULAR SHELL KWA DEPUY INTL., LTD. ¿ REG. # 8010379 256793

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention