BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM LT IBP MED HUMERAL COMP

    MDR report key: 8429227 · Received March 18, 2019

    Report

    Report Number
    0001825034-2019-01117
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    May 16, 2012
    Report Date
    June 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDB
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: THE COMPLAINT CANNOT BE CONFIRMED AS NO MEDICAL RECORDS WERE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 114368 IBP ULNA LEFT STD INTLK 221552. THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT ELBOW ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY TEN (10) YEARS POST-IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222448 CUSTOM LT IBP MED HUMERAL COMP PROSTHESIS, ELBOW JDB ZIMMER BIOMET, INC. N/A 750420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R