BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA CEMENTED TIBIAL COMPONENT

    MDR report key: 5391002 · Received January 26, 2016

    Report

    Report Number
    2648920-2016-00017
    Event Type
    Injury
    Date Received
    January 26, 2016
    Report Date
    January 4, 2016
    Manufacturer
    ZIMMER, TURPEAUX INDUSTRIAL PARK
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG #4251200051, PERSONA VIVACIT E ARTICULAR SURFACE, LOT #62910518; MANUFACTURED AT ZIMMER BIOMET, INC., (B)(4). CATALOG #42502206201, PERSONA CR FEMORAL COMPONENT, LOT #62691354; MANUFACTURED AT ZIMMER BIOMET, INC., (B)(4). CATALOG #42557000114, PERSONA TAPER STEM IMPLANT, LOT #63110160; MANUFACTURED AT ZIMMER BIOMET, INC., (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE RELATED PART AND LOT COMBINATIONS. OPERATIVE NOTES FROM THE PATIENT¿S PREVIOUS LEFT KNEE REVISION SURGERY INDICATE THE PRESS-FIT TIBIAL COMPONENT WAS REVISED TO A CEMENTED TIBIAL COMPONENT WITH A STEM EXTENSION. THE FEMORAL AND PATELLAR COMPONENTS WERE NOTED TO BE IN GOOD CONDITION AND WERE LEFT ALONE. WELL BALANCED GAPS, NEUTRAL EXTENSION, 135 DEGREES OF FLEXION, AND EXCELLENT TRACKING OF THE PATELLA WERE NOTED AFTER THE TIBIAL COMPONENT WAS IMPLANTED. PER THE PERSONA KNEE SYSTEM PACKAGE INSERT, PAIN IS A KNOWN RISK OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT IS STILL EXPERIENCING PAIN AFTER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49247 PERSONA CEMENTED TIBIAL COMPONENT JWH JWH ZIMMER, TURPEAUX INDUSTRIAL PARK N/A 63112124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other