BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SCREW

    MDR report key: 10134379 · Received June 9, 2020

    Report

    Report Number
    0001822565-2020-02059
    Event Type
    Injury
    Date Received
    June 9, 2020
    Date of Event
    January 8, 2020
    Report Date
    June 8, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-00414, 0001822565-2020-00415, 0001822565-2020-02060, 0001822565-2020-02061, 0001822565-2020-02062. CONCOMITANT MEDICAL PRODUCTS: UNK POLY, ITEM# 00434901413, LOT#64141262. UNK GLENOID HEAD, UNK BASEPLATE, UNK SCREW. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. MEDICAL RECORDS WERE NOT PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS FOR OTHER DEVICES, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT 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 · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A REVERSE SHOULDER OVER A YEAR AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED A COUPLE OF MONTHS AGO DUE TO THE POLY DISENGAGING FROM THE STEM. A SECOND REVISION WAS RECENTLY PERFORMED DUE TO ANOTHER DISENGAGED POLY AND POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595553 UNK SCREW PROSTHESIS, EXTREMITIES KWS ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R