BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENDER SOLUTIONS FEMORAL COMPONENT

    MDR report key: 5050805 · Received September 2, 2015

    Report

    Report Number
    1822565-2015-01630
    Event Type
    Injury
    Date Received
    September 2, 2015
    Report Date
    August 5, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KRR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). OTHER DEVICE USED: CATALOG #00597206632 , NEXGEN PROLONG ALL POLY PATELLA, LOT #62882840. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THESE DEVICES ARE USED FOR TREATMENT. NO IMPLANTS OR PICTURES PROVIDED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE DEVICES WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. COMPATIBILITY OF THE DEVICES WERE REVIEWED WITH NO ISSUES FOUND. A COMPLAINT HISTORY SEARCH FOUND NO OTHER COMPLAINTS FOR THE ASSOCIATED PART/LOT COMBINATIONS. A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING POSTOPERATIVE SWELLING AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581383 GENDER SOLUTIONS FEMORAL COMPONENT KRR KRR ZIMMER INC 62806536

    Patients

    Seq Age Sex Outcome Treatment
    1 Other