BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA STEMMED TIBIAL PLATE

    MDR report key: 5772384 · Received July 6, 2016

    Report

    Report Number
    0002648920-2016-00916
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    June 10, 2016
    Report Date
    February 8, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZIMMER PERSONA ARTICULAR SURFACE CATALOG #: 42-5224-007-10 LOT #: 62775465. ZIMMER PERSONA CEMENTED FEMORAL COMPONENT CATALOG #: 42-5006-066-02 LOT #: 62786359. ZIMMER PERSONA ALL-POLY PATELLA CATALOG #: 42-5402-000-38 LOT #: 62841967. ZIMMER HEADLESS DRILL PIN CATALOG #: 00-5901-020-00 LOT #: 62865826. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS IS REPORT 1 OF 2 FOR THIS PATIENT. SEE ALSO 0001822565-2016-02296-1. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT AND ARTICULAR SURFACE IDENTIFIED NO DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. OPERATIVE NOTES FROM THE PRIMARY SURGERY STATE THAT THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DUE TO END-STAGE OSTEOARTHRITIS. EXCELLENT STABILITY AND RANGE OF MOTION WERE NOTED DURING TRIALING WITH PROVISIONALS. IT WAS NOTED THAT AFTER IMPLANTATION OF THE FINAL COMPONENTS, THE ARTICULAR SURFACE WAS INSERTED AND THE KNEE WAS REDUCED ¿ONCE THE CEMENT BEGAN TO HARDEN.¿ REVIEW OF THE IMPLANTED COMPONENTS IDENTIFIED NO COMPATIBILITY ISSUES. OFFICE VISIT NOTES FROM APPROXIMATELY ONE YEAR FIVE MONTHS AFTER THE PRIMARY SURGERY STATE THAT THE PATIENT HAS HAD A PERSISTENTLY PAINFUL AND STIFF KNEE. THE PATIENT ALSO HAD A FLEXION CONTRACTURE OF APPROXIMATELY 25 DEGREES. THE NOTES STATE THE REVIEW OF IMAGING OF THE RIGHT KNEE DID NOT DEMONSTRATE SIGNIFICANT ROTATIONAL ABNORMALITIES OF EITHER THE FEMORAL OR TIBIAL COMPONENTS. THE NOTES ALSO STATE THAT THE FINDINGS OF THE BONE SCAN SUGGEST THE COMPONENTS COULD BE LOOSE BUT X-RAYS INDICATED THEY WERE REASONABLY FIXED. OPERATIVE NOTES FROM THE REVISION SURGERY STATE THE PATIENT WAS REVISED DUE TO A FAILED RIGHT TKA AND LOOSE TIBIAL COMPONENT. THE TIBIAL COMPONENT WAS NOTED TO BE COMPLETELY LOOSE EXCEPT FOR THE DISTAL POLYETHYLENE PLUG, WHICH WAS NOTED TO BE WELL FIXED. THE FEMORAL COMPONENT WAS REVISED USING A SAGITTAL SAW TO DISRUPT THE CEMENT INTERFACE. THE PATELLAR COMPONENT WAS NOTED TO BE WELL-FIXED AND WAS NOT REVISED. PER THE PERSONA KNEE SYSTEM PACKAGE INSERT, LOOSENING OF THE PROSTHETIC KNEE COMPONENTS AND POOR RANGE OF MOTION ARE KNOWN RISKS OF THIS PROCEDURE. IN THE INSTRUCTIONS FOR IMPLANTING THE FINAL COMPONENTS, THE PERSONA SURGICAL TECHNIQUE STATES, ¿ALLOW THE CEMENT TO FULLY CURE BEFORE PERFORMING A TRIAL ROM OR INSERTING THE ARTICULAR SURFACE.¿ INSERTING THE ARTICULAR SURFACE AND PERFORMING A TRIAL ROM PRIOR TO THE BONE CEMENT BEING COMPLETELY CURED CAN CAUSE THE CEMENTED COMPONENTS TO SHIFT THEIR POSITION, WHICH COULD AFFECT THE COMPONENT ALIGNMENT, OR CAN IMPEDE FIXATION OF THE DEVICES, WHICH COULD RESULT IN LOOSENING. BASED ON THE AVAILABLE INFORMATION, IT APPEARS THAT INSERTING THE ARTICULAR SURFACE AND TRIALING PRIOR TO THE BONE CEMENT CURING IS THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO STIFFNESS AND LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425855 PERSONA STEMMED TIBIAL PLATE KNEE PROSTHESIS JWH ZIMMER MANUFACTURING B.V. N/A 62735652

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R