BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM DIA TPRD HD PER SCRW 45

    MDR report key: 3093610 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-16558
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    JDL
    PMA / PMN Number
    PK861979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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 DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. REVISION OPERATIVE RECORDS WERE OBTAINED. REVIEW OF PROVIDED MEDICAL RECORDS CONFIRMS THE REPORTED LOOSENING AND METALOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP. OSTEOLYSIS AND POLY WEAR WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197084 5.0MM DIA TPRD HD PER SCRW 45 BONE SCREW JDL 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC C13NX4000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention