BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL HIP BALL 32MM +11

    MDR report key: 3233557 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21564
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK860701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. PATIENT WAS REVISED TO ADDRESS DISLOCATION. THE REPORT STATES THAT THE PATIENT IS MOST LIKELY NON-COMPLIANT. DOI (B)(6) 2003 - DOR (B)(6) 2013 (RIGHT HIP). 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 SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS WERE OBTAINED. THEY ARE 2003 PRIMARY SURGICAL NOTES AND DO NOT OFFER ANY INFORMATION REGARDING THIS REVISION. 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. 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

    PATIENT WAS REVISED TO ADDRESS DISLOCATION. THE REPORT STATES THAT THE PATIENT IS MOST LIKELY NON-COMPLIANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333837 TOTAL HIP BALL 32MM +11 FEMORAL HEAD JDI 1818910 DEPUY ORTHOPAEDICS, INC. V68GC1016

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention