BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HUMERAL COMPONENT

    MDR report key: 10905067 · Received November 25, 2020

    Report

    Report Number
    0001822565-2020-03915
    Event Type
    Injury
    Date Received
    November 25, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWJ
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G4; G7; H1; H2 UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. SALES REP INDICATED THE SURGEON HAD ONLY SWAPPED THE AXEL AND BEARING COMPONENT; THEREFORE, THE HUMERAL COMPONENT DID NOT NEED TO BE REPORTED. THE INITIAL REPORT SHOULD BE VOIDED. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 03914. CONCOMITANT MEDICAL PRODUCTS: UNK ULNAR COMPONENT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 PATIENT HAS BEEN INDICATED FOR REVISION DUE TO AN UNSPECIFIED INFECTION; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364418 UNK HUMERAL COMPONENT PROSTHESIS, EXTREMITIES KWJ ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other