BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN ALLPOLY TIB LM/RL S4 7MM

    MDR report key: 2770054 · Received October 3, 2012

    Report

    Report Number
    1818910-2012-21575
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    HRY
    PMA / PMN Number
    K010810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE CEMENT AND FEMUR AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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 POLY WEAR AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRSVN ALLPOLY TIB LM/RL S4 7MM TIBIAL KNEE PROSTHESIS HRY DEPUY RAYNHAM XJ1CX4

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention