BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXED LOCKING SCREW 4.75MMX15MM

    MDR report key: 6298712 · Received February 2, 2017

    Report

    Report Number
    0001825034-2017-00432
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    November 21, 2016
    Report Date
    February 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWJ
    PMA / PMN Number
    PK080426
    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. (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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-05448 AND 1825034-2017-00432).

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79503 FIXED LOCKING SCREW 4.75MMX15MM PROSTHESIS, WRIST JWJ BIOMET ORTHOPEDICS N/A 761190

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R