BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAESTRO WRIST RADIAL COMPONENT

    MDR report key: 6367743 · Received March 1, 2017

    Report

    Report Number
    0001825034-2017-01262
    Event Type
    Injury
    Date Received
    March 1, 2017
    Report Date
    March 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWN
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WERE NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. (B)(4). INITIAL REPORTER - CULP, RANDALL W.; BACHOURA, ABDO; GELMAN, SCOTT E.; AND JACOBY, SIDNEY M.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, " PROXIMAL ROW CARPECTOMY COMBINED WITH WRIST HEMIARTHROPLASTY " WHICH AIMED TO PRESENT EARLY EXPERIENCE WITH PROXIMAL ROW CARPECTOMY (PRC) COMBINED WITH DISTAL RADIUS HEMIARTHROPLASTY USING THE MAESTRO WRIST RECONSTRUCTIVE SYSTEM RADIAL COMPONENT, MANUFACTURED BY LEGACY BIOMET FROM APRIL 2009 TO JUNE 2010. A COMPETITOR PRODUCT WAS USED FROM SEPTEMBER 2010 ONWARDS. SEVENTEEN PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT PROXIMAL ROW CARPECTOMY COMBINED WITH DISTAL RADIUS HEMIARTHROPLASTY WITH A MAESTRO RADIAL COMPONENT ON AN UNKNOWN DATE. MEAN POSTOPERATIVE FLEXION, EXTENSION, AND GRIP STRENGTH WERE ALL LESS THAN PREOPERATIVE LEVELS. IT WAS REPORTED THAT AN (B)(6) FEMALE WITH A HISTORY OF OSTEOARTHRITIS UNDERWENT RIGHT WRIST ARTHROPLASTY. PATIENT SUBSEQUENTLY EXPERIENCED ULNAR TUNNEL SYNDROME AND UNDERWENT ULNAR NERVE NEUROLYSIS AND ULNAR TUNNEL DECOMPRESSION. AT THE 24 MONTH FOLLOWUP, PATIENT REPORTED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152399 UNKNOWN MAESTRO WRIST RADIAL COMPONENT PROSTHESIS, WRIST KWN BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R