BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEHNING RT NXL ULNA 125MM SEG

    MDR report key: 8950038 · Received August 30, 2019

    Report

    Report Number
    0001825034-2019-03885
    Event Type
    Injury
    Date Received
    August 30, 2019
    Report Date
    January 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS : COMPR SRS 60MM DST HML BDY RT PART#110029939 LOT#637220.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 211254, COMPR SRS 60MM DST HML BDY RT, 366310; 211261, COMPR SRS MOD STEM - 9X200MM, 457560; 211226, COMPR SRS IC SEG - 90MM, 409790. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03865. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [REMAINS IMPLANTED]. THE INVESTIGATION IS IN PROCESS, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ELBOW IS INDICATED FOR REVISION THREE (3) YEARS POST IMPLANTATION IN ORDER TO DECREASE SOFT TISSUE COMPROMISE AT THE ULNA/HUMERAL JUNCTION. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE PLAN IS TO REVISE THE CONNECTOR BETWEEN ULNA AND HUMERAL COMPLEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745251 BEHNING RT NXL ULNA 125MM SEG PROSTHESIS, ELBOW JDC ZIMMER BIOMET, INC. N/A 541180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10