BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER KNEE

    MDR report key: 4861470 · Received June 19, 2015

    Report

    Report Number
    1822565-2015-00946
    Event Type
    Injury
    Date Received
    June 19, 2015
    Report Date
    May 18, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THESE DEVICES ARE USED FOR TREATMENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED; HOWEVER, THE COMPLAINT MAY BE REOPENED UPON RETURN OF PRODUCT OR FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING SWELLING AT THE ANKLES AND PAIN TO THE TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401240 UNKNOWN ZIMMER KNEE KNEE PROSTHESIS JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other