BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 9596427 · Received January 16, 2020

    Report

    Report Number
    0001822565-2020-00199
    Event Type
    Injury
    Date Received
    January 16, 2020
    Report Date
    January 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S ARE ASSOCIATED WITH THIS REPORTING: 0001822565 - 2020 - 00200, 0001825034 - 2019 - 04057. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PART/LOT, UNKNOWN STEM, 11-210099 EXPLOR IMPLANT LOCKING SCREW LOT 690690. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO THE LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE AS NO PART/LOT WAS PROVIDED. ROOT CAUSE IS UNKNOWN. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS EXPERIENCING RANGE OF MOTION ISSUES IN EXTENSION SINCE THE LOCKING SCREW WAS REVISED. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61736 UNKNOWN HEAD PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other