BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL COMPONENT

    MDR report key: 12939223 · Received December 6, 2021

    Report

    Report Number
    0001822565-2021-03428
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 28, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWJ
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H10. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THE PIN IS FRACTURED. DAMAGE CAN ALSO BE SEEN ON THE BEARINGS HOWEVER IT IS UNKNOWN WHETHER THAT OCCURRED IN VIVO OR DURING THE EXPLANTATION. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). IMPLANT DATE: 2005. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED AND THE PIN/BUSHING WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELBOW REPLACEMENT SURGERY ON AN UNKNOWN DATE IN 2005. THE PATIENT WAS REVISED WITH A NEW PIN AND BUSHING DUE TO A CM ELBOW LOCKING PIN DISRUPTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837775 UNKNOWN HUMERAL COMPONENT PROSTHESIS, ELBOW KWJ ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H UNKNOWN ITEM UNKNOWN ULNA COMPONENT UNKNOWN LOT