BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA PEGGED POROUS TIBIAL COMPONENT

    MDR report key: 5393189 · Received January 27, 2016

    Report

    Report Number
    1822565-2016-00144
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    January 4, 2014
    Report Date
    October 13, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    OIY
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    Z-1266-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE DEVICE WERE REVIEWED AND IDENTIFIED NO DEVIATIONS OR ANOMALIES. THESE DEVICES ARE USED FOR TREATMENT. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE DEVICES INVOLVED WERE VERIFIED FOR COMPATIBILITY WITH NO COMPATABILITY ISSUES NOTED. COMPLAINT HISTORY SEARCH BASED ON THE PRODUCT AND LOT COMBINATION REVEALED NO SIMILAR COMPLAINTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4) OTHER DEVICES USED: CATALOG #42512000414, PERSONA CR VIVACITE ARTICULAR SURFACE, LOT #62280946. 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. CONCOMITANT PRODUCTS: TRABECULAR METAL STANDARD PRIMARY PATELLA ¿ CAT. NO. 00-5878-065-32, LOT NO. 62530446, FEMUR CR STANDARD ¿ CAT. NO. 42-5028-060-01; LOT NO. 62407733, ARTICULAR SURFACE ¿ CAT. NO. 42-5120-004-14; LOT NO. 62280946.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS MOST LIKELY DUE TO THE TIBIA POTENTIALLY ALLOWING FOR THE TIBIAL IMPLANT TO SIT PROUD ON THE RESECTED TIBIAL SURFACE. THEREFORE, THE TIBIA HAS LESS INITIAL STABILITY. THE PROBLEM WITH THIS DEVICE CONSTITUTES AS A DESIGN ISSUE AS THE ROOT CAUSE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND INABILITY TO BEND THE LEFT KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND INABILITY TO BEND THE LEFT KNEE. IT WAS INDICATED LATER THAT THE TIBIAL COMPONENT WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51299 PERSONA PEGGED POROUS TIBIAL COMPONENT OIY OIY ZIMMER INC 62318916

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention