BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX20MM

    MDR report key: 3223445 · Received July 12, 2013

    Report

    Report Number
    1818910-2013-21047
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    January 2, 2013
    Report Date
    June 14, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    NDJ
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE STEM'S DEVICE HISTORY RECORD DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. MEDICAL RECORDS, INCLUDING X-RAYS WERE OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND AN EXTENDED TROCHE. UPDATE: (B)(6) 2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS LEG LENGTH DISCREPANCY AND PERSISTENT PAIN. A FEMORAL STEM, HEAD, LINER, INSERT, SHELL, AND TWO SCREWS ARE BEING ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324497 PINN CAN BONE SCREW 6.5MMX20MM BONE SCREW NDJ 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC Z36KE4000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention