BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 10535386 · Received September 15, 2020

    Report

    Report Number
    0001825034-2020-03504
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    August 4, 2020
    Report Date
    November 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K193373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). REPORTED EVENT WAS CONFIRMED PER VISUAL INSPECTION OF THE D TRAY WHICH WAS FRACTURED AT THE POST POSITION. THE BODY HAD THE REMAINING PORTION OF THE TRAY FRACTURE STUCK INSIDE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). (UDI): N/A. MEDICAL PRODUCT: CATALOG #: 211219, COMPR SRS PROX BDY - LG 52MM, LOT # 760060; CATALOG #: EP-115397, E1 44-41 STD +3 HMRL BRG, LOT # 808390. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03219.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED APPROXIMATELY 6 YEARS AGO. THE PATIENT CAME INTO CLINIC WITH PAIN AND THE X-RAY SHOWED THE IMPLANT WAS BROKEN IN SOME WAY. SUBSEQUENTLY, THE PATIENT WAS REVISED ABOUT 2 WEEKS AGO. ATTEMPTS HAVE BEEN MADE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997828 COMP RVS TRAY CO 44MM PROSTHESIS ELBOW KWS ZIMMER BIOMET, INC. N/A 906990

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R