BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO TOTAL WRIST RADIAL STEM 7.5MM X 40MM

    MDR report key: 1723489 · Received June 15, 2010

    Report

    Report Number
    1825034-2010-00214
    Event Type
    Injury
    Date Received
    June 15, 2010
    Date of Event
    August 11, 2009
    Report Date
    March 25, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWJ
    PMA / PMN Number
    K042032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS INITIALLY REPORTED ON APRIL 19, 2010 AS A REVISION OF A MAESTRO WRIST ON MEDWATCH REPORT NUMBER 1825034-2010-00122. AT THE TIME, NO PRODUCT IDENTIFICATION WAS AVAILABLE. SUBSEQUENTLY, PRODUCT IDENTIFICATION HAS BEEN PROVIDED AND ADDITIONAL INFORMATION HAS BEEN REPORTED BY THE SURGEON STATING THAT THE REASON FOR REVISION WAS DUE TO INFECTION AND NOT AN IMPLANT ISSUE.THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. (B) (4).

    Additional Manufacturer Narrative · 1

    CATALOG # - WAS MISSING A DIGIT, CORRECTED TO 180182.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A WRIST PROCEDURE AND WAS SUBSEQUENTLY REVISED FOR NON-PROSTHETIC RELATED REASONS ON (B) (6) 2009. DURING THE REVISION PROCEDURE, THE SURGEON FOUND EVIDENCE OF METALLOSIS IN THE AREA WHERE THE TITANIUM SCREW AND THE CARPAL PLATE INTERFACE. THE SURGEON REPORTED THE METALLOSIS WAS DUE TO THE FRETTING OF THE SCREW AND THE CARPAL PLATE. IT WAS FURTHER REPORTED BY THE SURGEON THAT THE REVISION WAS DUE TO INFECTION AND NOT DUE TO IMPLANT ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A WRIST PROCEDURE AND WAS SUBSEQUENTLY REVISED FOR NON-PROSTHETIC RELATED REASONS ON (B) (6) 2009. DURING THE REVISION PROCEDURE, THE SURGEON FOUND EVIDENCE OF METALLOSIS IN THE AREA WHERE THE TITANIUM SCREW AND THE CARPAL PLATE INTERFACE. THE SURGEON REPORTED THE METALLOSIS WAS DUE TO THE FRETTING OF THE SCREW AND THE CARPAL PLATE. IT WAS FURTHER REPORTED BY THE SURGEON THAT THE REVISION WAS DUE TO INFECTION AND NOT DUE TO IMPLANT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO TOTAL WRIST RADIAL STEM 7.5MM X 40MM PROSTHESIS, WRIST JWJ BIOMET ORTHOPEDICS N/A 294070

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R