BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA CEMENTED STEMMED TIBIAL COMPONENT

    MDR report key: 5554108 · Received April 7, 2016

    Report

    Report Number
    2648920-2016-00105
    Event Type
    Injury
    Date Received
    April 7, 2016
    Report Date
    February 6, 2017
    Manufacturer
    ZIMMER, TURPEAUX INDUSTRIAL PARK
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG # 00597206532, NEXGEN ALL POLY PATELLA, LOT # 62268003. CATALOG # 42500006402, PERSONA PS CEMENTED FEMORAL, LOT # 62193259, MANUFACTURED BY: ZIMMER LTD., (B)(4). CATALOG # 42522400712, PERSONA PS VIVACIT-E ARTICULAR SURFACE, LOT # 62315376, MANUFACTURED BY: ZIMMER INC., (B)(4). CATALOG # 00111214001, PALACOS R BONE CEMENT, LOT # 75344317 - THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT, FEMORAL COMPONENT, AND BONE CEMENT IDENTIFIED NO DEVIATIONS OR ANOMALIES. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THESE DEVICES ARE USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR L/N 62354488, 62193259, OR 75344317. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE LEGAL CLAIM STATES THAT THE PATIENT SUFFERED FROM MECHANICAL LOOSENING OF THE IMPLANTED COMPONENTS, BUT DOES NOT SPECIFY WHICH COMPONENTS WERE LOOSE. PER THE PERSONA KNEE SYSTEM PACKAGE INSERT, LOOSENING 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 THE PATIENT IS SCHEDULED FOR A REVISION DUE TO PAIN, STIFFNESS, LIMITED MOBILITY, DEFORMITY OF TISSUE SURROUNDING THE KNEE, AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209691 PERSONA CEMENTED STEMMED TIBIAL COMPONENT JWH JWH ZIMMER, TURPEAUX INDUSTRIAL PARK 62354488

    Patients

    Seq Age Sex Outcome Treatment
    1 Other