BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS MENIS BEARING STD+/10MM

    MDR report key: 3180049 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19397
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    PP910016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. REQUESTS WERE MADE FOR FURTHER INFORMATION TO ASSIST IN THE INVESTIGATION BUT NO MORE INFORMATION WAS MADE AVAILABLE. A COMPLAINT SEARCH AND A REVIEW OF THE MANUFACTURING RECORDS WERE CARRIED OUT. NO ANOMALIES OR PREVIOUS COMPLAINTS WERE FOUND RELATING TO THE PROVIDED LOT NUMBER. SHOULD ADDITIONAL INFORMATION BE RECEIVED THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO INSERT WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280537 LCS MENIS BEARING STD+/10MM TIBIAL BEARING NJL DEPUY ORTHOPAEDICS WNP40

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention