BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAESTRO WRIST

    MDR report key: 6204753 · Received December 27, 2016

    Report

    Report Number
    0001825034-2016-05319
    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. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - NI DEVICE PRODUCT CODE - NI EXPIRATION DATE - NI DATE IMPLANTED - NI DATE EXPLANTED - NI (B)(6), MANUFACTURE DATE ¿ NI.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THREE PATIENT¿S UNDERWENT TOTAL WRIST ARTHROPLASTY. FOLLOW UP RESULTS INDICATED POSTOPERATIVE FAILURE OF BOTH COMPONENTS. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857280 UNKNOWN MAESTRO WRIST PROSTHESIS, WRIST JWJ BIOMET ORTHOPEDICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R