BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX25MM

    MDR report key: 3944495 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23766
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    February 18, 2003
    Report Date
    June 19, 2014
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER RELATED REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT ¿THE CLINICAL REPORT STATES PATIENT HAD SURGICAL INTERVENTION DUE TO DEEP INFECTION. REC¿D (B)(6) 2014, RIGHT HIP; AE/INFECTION-DEEP. SEVERE, SERIOUS. REVISION/INFECTION.UPDATE RECEIVED 6/19/14. CLINICAL REPORT RECEIVED. DATE OF REVISION HAS BEEN UPDATED. PART AND LOT INFORMATION HAS BEEN PROVIDED FOR THE SCREWS AND THE SLEEVE. COMPLAINT WAS UPDATED ON 7/15/14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421865 PINN CAN BONE SCREW 6.5MMX25MM HIP OTHER IMPLANT NDJ DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655 WT6B61245

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention