BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS MV+G 1X40

    MDR report key: 8604277 · Received May 13, 2019

    Report

    Report Number
    0001822565-2019-01956
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    May 19, 2016
    Report Date
    September 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    UNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PERSONA PS ARTICULAR SURFACE; CEMENTED PERSONA NATURAL TIBIA; PERSONA CEMENTED FEMUR PS. REPORT SOURCE FOREIGN - (B)(6). CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-01955.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT REVISION KNEE ARTHROPLASTY APPROXIMATELY 18 MONTHS POST-IMPLANTATION DUE TO PAIN, LACK OF MOBILITY AND INSTABILITY. DURING THE REVISION THE ARTICULAR SURFACE WAS REPLACED AND CEMENT DEBRIS REMOVED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398929 PALACOS MV+G 1X40 CEMENT LOD ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R