BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAESTRO WRIST

    MDR report key: 6204731 · Received December 27, 2016

    Report

    Report Number
    0001825034-2016-05287
    Event Type
    Injury
    Date Received
    December 27, 2016
    Report Date
    December 27, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWJ
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FOUR PATIENTS UNDERWENT TOTAL WRIST ARTHROPLASTY AND REPORTED POSTOPERATIVE SOFT TISSUE IMBALANCE POST IMPLANTATION. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856307 UNKNOWN MAESTRO WRIST PROSTHESIS, WRIST JWJ BIOMET ORTHOPEDICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R