BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN FB INS RM/LL S2 9.5MM

    MDR report key: 4231259 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31288
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    HRY
    PMA / PMN Number
    PK040268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING AND POLY WEAR. LOOSENING OCCURRED AT THE CEMENT/IMPLANT INTERFACE. CEMENT WAS MANUFACTURED BY DEPUY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715361 PRSVN FB INS RM/LL S2 9.5MM KNEE TIBIAL BEARING/INSERT HRY DEPUY IRELAND 9616671 2113031

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention