BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA 2 PEG POROUS TIBIAL COMPONENT

    MDR report key: 5230240 · Received November 17, 2015

    Report

    Report Number
    1822565-2015-02392
    Event Type
    Injury
    Date Received
    November 17, 2015
    Date of Event
    December 3, 2014
    Report Date
    January 16, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    MBH
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    Z-1266-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES AND PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED SINCE ITEM AND LOT NUMBERS ARE UNKNOWN. THESE DEVICES ARE USED FOR TREATMENT. 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 DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED RELATED TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZIMMER PERSONA FEMORAL COMPONENT, CATALOG #: 42-5022-062-02, LOT #: 62432337. ZIMMER PERSONA ARTICULAR SURFACE, CATALOG #: 42-5220-004-11, LOT #: 62334534. PALACOS BONE CEMENT, CATALOG #: 00-1113-140-01, LOT # 75984320. 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 IDENTIFIED NO DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY REVIEW IDENTIFIED NO ADDITIONAL COMPLAINTS FOR LOT 62337328. OPERATIVE NOTES FROM THE PRIMARY SURGERY STATE THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT. TRIAL REDUCTION WITH THE PROVISIONAL DEVICES WAS NOTED TO BE STABLE IN ALL PLANES. THE TIBIAL AND FEMORAL COMPONENTS WERE PRESS-FIT IN PLACE AND THE PATELLAR COMPONENT WAS IMPLANTED WITH BONE CEMENT. NO COMPLICATIONS WERE NOTED. REVIEW OF THE IMPLANTED DEVICES IDENTIFIED NO COMPATIBILITY ISSUES. OPERATIVE NOTES FROM THE REVISION SURGERY STATE THE PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING. THE TIBIAL COMPONENT WAS NOTED TO BE WELL INGROWN ALONG THE ANTERIOR PORTION BUT THERE WAS NO BONY INGROWTH POSTERIORLY. THE PATELLAR AND FEMORAL COMPONENTS WERE NOTED TO BE WELL FIXED AND WERE NOT REVISED. A FIELD ACTION WAS CONDUCTED ON FEBRUARY 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ABOUT 10 PATIENTS WHO HAVE RECEIVED PERSONA TM TIBIAL COMPONENTS HAVE BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759105 PERSONA 2 PEG POROUS TIBIAL COMPONENT MBH MBH ZIMMER INC N/A 62337328

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention