BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO TOTAL WRIST TAPERED CARPAL HEAD 7MM X 15MM STANDARD

    MDR report key: 6214297 · Received December 29, 2016

    Report

    Report Number
    0001825034-2016-05448
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    November 21, 2016
    Report Date
    May 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWN
    PMA / PMN Number
    PK050028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. DEVICE PRODUCT CODE ¿ KWN. (B)(4). CONCOMITANT PRODUCTS: MAESTRO TOTAL WRIST RADIAL STEM: CATALOG #:180182, LOT #:003990. MAESTRO TOTAL WRIST RIGHT DISTAL RADIAL BODY: CATALOG #:180151, LOT #:490430. MAESTRO TOTAL WRIST CAPITATE STEM FOR TAPERED PLATE: CATALOG #:180320, LOT #:961000. MAESTRO TOTAL WRIST TAPERED CARPAL PLATE: CATALOG #:180395, LOT #:741150. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-05448 AND 1825034-2017-00432).

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. ROOT CAUSE REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT REVISION TOTAL WRIST ARTHROPLASTY 19 DAYS POST-IMPLANTATION DUE TO INFECTION. THE CARPAL HEAD AND TWO SCREWS WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT TOTAL WRIST ARTHROPLASTY AND IS BEING CONSIDERED FOR A REVISION PROCEDURE DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864176 MAESTRO TOTAL WRIST TAPERED CARPAL HEAD 7MM X 15MM STANDARD PROSTHESIS, WRIST KWN BIOMET ORTHOPEDICS N/A 133000

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| O| R