BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN.6.5 CANCELLOUS SCREW 20MM

    MDR report key: 2983517 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-12940
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    1219655 DEPUY RAYNHAM
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF A PHOTOGRAPHED X-RAY CANNOT CONFIRM THE REPORTED CUP MIGRATION AS THE IMAGE IS NOT DATED, IT IS NOT KNOWN IF IT IS POST-PRIMARY OR PRE-REVISION, AND NO OTHER X-RAY HAS BEEN RECEIVED TO REFERENCE TOO. THE PATIENT WAS REPORTEDLY IMPLANTED IN 2009 AND REVISED IN (B)(6) 2013. IT IS NOT REASONABLE TO CONCLUDE THE DEPUY DEVICES CONTRIBUTED TO THE REPORTED INFECTION FOUR YEARS POST-PRIMARY. 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 IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A CUP THAT HAD DEVIATED FROM ITS ORIGINAL PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86855 PINN.6.5 CANCELLOUS SCREW 20MM BONE SCREW NDJ 1219655 DEPUY RAYNHAM CB5FT4000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention