BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS TIB HINGE INSERT MED 31MM

    MDR report key: 2841542 · Received November 21, 2012

    Report

    Report Number
    1818910-2012-27928
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    KRO
    PMA / PMN Number
    K011810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED THE METAL POST COMPONENT IS FRACTURED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. 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 WI-7915 APPENDIX A; REV. C.. NO INFORMATION WAS OBTAINED. THE INVESTIGATION DID NOT IDENTIFY THE ROOT CAUSE OF THE DEVICE FRACTURE. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. IN ADDITION, THE PRODUCT CODE IS AN OBSOLETE ITEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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 A BROKEN POST ON THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LPS TIB HINGE INSERT MED 31MM TIBIAL KNEE INSERT KRO DEPUY RAYNHAM CX8DF4000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention