BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAESTRO WRIST

    MDR report key: 6209237 · Received December 28, 2016

    Report

    Report Number
    0001825034-2016-05332
    Event Type
    Injury
    Date Received
    December 28, 2016
    Report Date
    December 20, 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. HOWEVER, THE IMPLANTS IN THIS ARTICLE WERE USED IN A CEMENTLESS CONSTRUCT, AND IT IS NOTED THAT THE CEMENTLESS CONSTRUCT IS OFF-LABEL USE. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2016-05332/0001825034-2017-00516/0001825034-2017-00523).

    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 IS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A TENDON REPAIR, TENDON TRANSFER, AND INTRINSIC RELEASE PROCEDURE AT 2.8 MONTHS POST-IMPLANTATION OF TOTAL WRIST ARTHROPLASTY DUE TO WRIST IMBALANCE WITH TENDON RUPTURES AND EXCESSIVE RADIAL DEVIATION. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A TENDON REPAIR AT 2.8 MONTHS POST-IMPLANTATION. PATIENT REPORTEDLY UNDERWENT IRRIGATION AND DEBRIDEMENT APPROXIMATELY 4.7 MONTHS POST-IMPLANTATION DUE TO INFECTION. FINALLY, ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS APPROXIMATELY, 8.1 MONTHS POST-IMPLANTATION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858056 UNKNOWN MAESTRO WRIST PROSTHESIS, WRIST JWJ BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R