BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL TIBIA (TM) TWO-PEG POROUS FIXED BEARING RIGHT SIZE E

    MDR report key: 15536696 · Received October 4, 2022

    Report

    Report Number
    0001822565-2022-02866
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    December 7, 2020
    Report Date
    October 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00889024510562
    PMA / PMN Number
    K173417
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ARTICULAR SURFACE FIXED BEARING (UC) RIGHT 12 MM HEIGHT. ITEM# 42522200512, LOT# 63777526. FEMUR TRABECULAR METAL (CR) STANDARD POROUS, ITEM 42502806402, LOT# 64368270. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THIRTEEN MONTHS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2778787 NATURAL TIBIA (TM) TWO-PEG POROUS FIXED BEARING RIGHT SIZE E PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 64405810 00889024510562

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H