BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAESTRO TOTAL WRIST

    MDR report key: 6210223 · Received December 28, 2016

    Report

    Report Number
    0001825034-2016-05348
    Event Type
    Injury
    Date Received
    December 28, 2016
    Report Date
    December 21, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWJ
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WERE NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. THE ARTICLE WAS WRITTEN BY SAGERFORS,MARCUS; GUPTA, ANIL; BRUS, OLE; RIZZO, MARCO; AND PETTERSSON, KURT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DEEP INFECTION. NO FURTHER INFORMATION IS AVAILABLE AND PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860160 UNKNOWN MAESTRO TOTAL WRIST PROSTHESIS, WRIST JWJ BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R