BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAESTRO WRIST

    MDR report key: 6204735 · Received December 27, 2016

    Report

    Report Number
    0001825034-2016-05289
    Event Type
    Injury
    Date Received
    December 27, 2016
    Report Date
    December 27, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KYI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MICHAEL P. GASPER- "COMPLICATIONS FOLLOWING PARTIAL AND TOTAL WRIST ARTHROPLASTY" 1-11. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. INITIAL REPORTER - JESSE LOU, PATRICK M. KANE, SIDNEY M. JACOBY, A. LEE OSTERMAN, AND RANDALL W. CULP.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO PATIENTS INITIALLY UNDERWENT DISTAL RADIUS HEMIARTHROPLASTY. BOTH PATIENTS INDICATED INFECTION (SUPERFICIAL) POST-OPERATIVELY. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857283 UNKNOWN MAESTRO WRIST PROSTHESIS, WRIST KYI BIOMET ORTHOPEDICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R