BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS 60MM DST HML BDY LT

    MDR report key: 8422483 · Received March 14, 2019

    Report

    Report Number
    0001825034-2019-01102
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    February 11, 2019
    Report Date
    August 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE COULD NOT BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 FROM THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 114700 DISC CONDYLE KIT W/HEXALOBULA, 054490; 130611 INTRAMEDULLARY PLUG 11-13MM, 804720; 114826 DISC ULNA 4X115MM LT W/BRNG C, 828090; 211224 COMPR SRS IC SEG - 30MM, 837690; 211236, COMPR SRS MOD STEM - 8X100MM, 482580. 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 INITIAL LEFT ELBOW PROCEDURE AND WAS SUBSEQUENTLY REVISED DUE TO UNKNOWN REASONS. THE PATIENT HAS NOW UNDERGONE A REVISION PROCEDURE DUE TO IMPLANT WEAR, DISASSOCIATION AND METALLOSIS APPROXIMATELY SEVEN (7) YEARS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215723 COMPR SRS 60MM DST HML BDY LT PROSTHESIS, ELBOW KWT ZIMMER BIOMET, INC. N/A 923660

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R