BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL STEM 75X12MM FLUTED

    MDR report key: 2955677 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-12065
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    PK063633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING REVIEW OF THE INFORMATION PROVIDED, IT WAS IDENTIFIED THAT INSUFFICIENT INFORMATION HAD BEEN PROVIDED TO VERIFY THE REPORTED INCIDENT. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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 COMPLAINING OF KNEE PAIN, REDUCED RANGE OF MOTION FOR MANY MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58612 UNIVERSAL STEM 75X12MM FLUTED FEMORAL STEM JWH DEPUY RAYNHAM EC1E24000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention