BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA PEGGED POROUS TIBIAL COMPONENT

    MDR report key: 4934526 · Received July 21, 2015

    Report

    Report Number
    1822565-2015-01246
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 19, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    Removal / Correction Number
    Z-1266-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED TIBIAL PLATE IDENTIFIED BOTH PEGS WERE CUT OFF. BOTH PEGS WERE RETURNED FOR REVIEW AND THERE WAS VISIBLE BONE INGROWTH ON ONE SIDE OF ONE PEG. THERE WAS SLIGHT FOREIGN MATERIAL IDENTIFIED ON THE DISTAL SURFACE OF THE PLATE, BUT NO INDICATION OF BONE INGROWTH. DAMAGE WAS NOTED ON THE ANTERIOR EDGE OF THE PLATE, LIKELY THE RESULT OF REMOVAL. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE FOUND. THESE DEVICES ARE USED FOR TREATMENT. THE PACKAGE INSERT STATES THAT "LOOSENING OF THE PROSTHETIC KNEE COMPONENTS" IS AN ADVERSE EFFECT. THIS IS THEREFORE A KNOWN INHERENT RISK OF THE PROCEDURE. 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 PRODUCT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATIONS. A FIELD ACTION WAS CONDUCTED ON 02/19/2015 IN WHICH ZIMMER VOLUNTARILY REMOVED THE PERSONA TRABECULAR METAL TIBIAL IMPLANT FROM THE FIELD DUE TO A HIGHER THAN ANTICIPATED COMPLAINT RATE FOR RADIOLUCENT LINES AND LOOSENING. THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION. FDA RECALL Z-1266-2015 CONTAINS THE RELATED TIBIAL LOT NUMBER. THE CAPA INVESTIGATION DETERMINED THAT THE LIKELY ROOT CAUSES FOR THE HIGHER THAN ANTICIPATED COMPLAINT RATE ARE THAT THE PERSONA TM TIBIA ALLOWS THE POTENTIAL FOR THE TIBIAL IMPLANT TO SIT PROUD ON THE RESECTED TIBIAL SURFACE AND THE PERSONA TM TIBIA HAS LESS INITIAL STABILITY THAN PREDICATE DEVICES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO SYMPTOMS OF PAIN IN TIBIAL TRAY AREA ON LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473161 PERSONA PEGGED POROUS TIBIAL COMPONENT OIY ZIMMER, INC. 62539130

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention