BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN ALLPOLY TIB RMLL SZ4 7MM

    MDR report key: 2850038 · Received November 29, 2012

    Report

    Report Number
    1818910-2012-28414
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    HRY
    PMA / PMN Number
    K010810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    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 SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. C. X-RAYS WERE THE ONLY INFORMATION 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS. LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/BONE INTERFACE WAS ALSO REPORTED; HOWEVER, COMPETITOR CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRSVN ALLPOLY TIB RMLL SZ4 7MM TIBIAL KNEE PROSTHESIS HRY DEPUY RAYNHAM XG9FP4008

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention