BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXEL ARTICULATION KIT SIZE 5/6

    MDR report key: 8171965 · Received December 17, 2018

    Report

    Report Number
    0001822565-2018-06973
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    October 30, 2018
    Report Date
    April 3, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    K123862
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED. UDI: (B)(4). THE COMPLAINT CAN BE CONFIRMED BASED ON THE MEDICAL RECORDS PROVIDED STATING PATIENT ADMITTED FROM EMERGENCY DEPARTMENT DUE TO RIGHT ELBOW WOUND DRAINAGE, FEVER, SWELLING, AND INCREASED PAIN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS MADE AVAILABLE AT THIS TIME TO REPORT

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 211225 COMPR SRS IC SEG - 60MM 875550, 211238 COMPR SRS MOD STEM - 12X100MM 653050, 110029938 COMPR SRS 50MM DST HUM BDY RT 213040, UNKNOWN NEXEL ULNAR COMPONENT. (B)(6). THE COMPLAINT IS UNDER 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: 0001822565 - 2018 - 06972.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT DISTAL HUMERAL RESECTION AND IMPLANTATION OF A DISTAL HUMERUS AND ELBOW ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED SUPERFICIAL WOUND INFECTION TWO WEEKS POST IMPLANTATION AND UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE FOR DEEP WOUND INFECTION SIX WEEKS POST IMPLANTATION. IT WAS REPORTED THAT THE INFECTION WAS RELATED TO PROCEDURE BUT NOT IMPLANTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011289 NEXEL ARTICULATION KIT SIZE 5/6 PROSTHESIS, ELBOW JDC ZIMMER BIOMET, INC. N/A 63991810

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R