BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM NRH TIB PLAT ASSY XS 12MM

    MDR report key: 2901873 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-10587
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK896048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. NO ADDITIONAL INFORMATION WAS 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BECAUSE SHE TWISTED WHILE BENDING OVER IN HER WHEELCHAIR AND DISLOCATED HER KNEE. THE METAL POST WAS DISLOCATED FROM THE POLY INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9194 SROM NRH TIB PLAT ASSY XS 12MM TIBIAL KNEE ASSEMBLY KRO DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS D51BV4

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention