BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA STEMMED CEMENTED TIBIAL PLATE

    MDR report key: 5061130 · Received September 8, 2015

    Report

    Report Number
    2648920-2015-00329
    Event Type
    Injury
    Date Received
    September 8, 2015
    Report Date
    May 8, 2015
    Manufacturer
    ZIMMER B.V.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG #42512400712, PERSONA VIVACIT E ARTICULAR SURFACE, LOT #62380396; MANUFACTURED AT ZIMMER INC., (B)(4). CATALOG #42500006401, PERSONA FEMORAL COMPONENT, LOT #62505707; MANUFACTURED AT ZIMMER LTD., (B)(4). DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE FOUND. UPDATED INFORMATION RECEIVED VIA OPERATIVE NOTES AND PRODUCT IDENTIFICATION LABELS. REVIEW OF PRIMARY OPERATIVE NOTES CONFIRMS PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. GAPS WERE MEASURED AND FOUND EQUAL AND WELL BALANCED. TRACKING OF THE PATELLA COMPONENT WAS ASSESSED AND FOUND TO BE ADEQUATE. FINAL COMPONENTS WERE CEMENTED INTO PLACE AND A 12MM ARTICULAR SURFACE WAS FOUND TO BE MOST APPROPRIATE. REVIEW OF PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. IT WAS REPORTED AT THIS TIME THAT THE PATIENT WAS TOLD BY AN ORTHOPEDIC SPECIALIST THAT THE KNEE HAS LOOSENED AND NEEDS TO BE REVISED SINCE IT IS UNSTABLE, BUT THIS CANNOT BE CONFIRMED. THE DATE OF THE PLANNED REVISION IS UNKNOWN. A PRODUCT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATIONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 1822565-2015-00879.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, SWELLING, STIFFNESS, LOOSENING, AND CLICKING SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593153 PERSONA STEMMED CEMENTED TIBIAL PLATE JWH JWH ZIMMER B.V. 62467139

    Patients

    Seq Age Sex Outcome Treatment
    1 Other