BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA PS CEMENTED FEMORAL COMPONENT

    MDR report key: 5181062 · Received October 27, 2015

    Report

    Report Number
    3007963827-2015-00037
    Event Type
    Injury
    Date Received
    October 27, 2015
    Report Date
    September 29, 2015
    Manufacturer
    ZIMMER, BUILDING #2
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG #42512400814, PERSONA PS VIVACITE ARTICULAR SURFACE, LOT #62349065 - MANUFACTURED BY ZIMMER INC - (B)(4). THE FOLLOWING DEVICES WERE MANUFACTURED BY ZIMMER (B)(4), CATALOG #42540200035, PERSONA ALL POLY PATELLA, LOT #62716026 . CATALOG #42532007501, PERSONA STEMMED CEMENTED TIBIAL COMPONENT, LOT #62676476. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING SEVERE PAIN WITH CONSTANT SWELLING AND INTERNAL BLEEDING AND WALKS WITH A CANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709817 PERSONA PS CEMENTED FEMORAL COMPONENT JWH JWH ZIMMER, BUILDING #2 62710580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other