BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 6

    MDR report key: 8033625 · Received November 2, 2018

    Report

    Report Number
    0001822565-2018-06068
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 2, 2018
    Report Date
    July 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF PROVISIONAL STEMMED TIBIAL AND ARTICULAR SURFACE PROVISIONAL EXHIBITS SIGNS OF REPEATED USE (NICKED OR GOUGED) AND ARE FRACTURED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE REPEATED USE OF THESE INSTRUMENTS WITH FIELD LIFE OF MORE THAN 07 YEARS; WHICH CAUSES WEAR AND TEAR TO THE INSTRUMENT AND LED TO THE FRACTURE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.  ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 06070 - 1.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 06068, 0001822565 - 2018 - 06070. PRODUCT IS IN PROCESS OF BEING RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROVISIONAL WERE FRACTURED DURING TOTAL KNEE SURGERY WHILE IMPACTION AND TEST REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874964 PERSONA PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 6 PROSTHESIS, KNEE HWT ZIMMER BIOMET, INC. N/A 61882576

    Patients

    Seq Age Sex Outcome Treatment
    1