BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSS PRESS FIT STEM SZ. 10

    MDR report key: 7918286 · Received September 28, 2018

    Report

    Report Number
    1651501-2018-00056
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 10, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K130050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DHR FOR PN STEM-0920-025-10, LOT 14-1955 SHOWED THERE WERE NO MATERIAL NONCONFORMANCES OR VARIANCES ASSOCIATED WITH THIS LOT. REVIEW OF THE SAMPLE LABEL INCLUDED IN THE DHR SHOWED THE EXPIRATION DATE OF JULY 2018. THE PRODUCT REMAINS IMPLANTED; THEREFORE NO FAILURE ANALYSIS CAN BE PERFORMED ON THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, AN EXPIRED IMPLANT WAS USED. THE SURGEON WAS NOTIFIED IMMEDIATELY AFTER THE IMPLANT WAS SEATED AND CHOSE TO LEAVE IT IN TO AVOID DAMAGE TO THE PATIENT. THE IMPLANTATION DATE WAS (B)(6) 2018 AND THE EXPIRATION DATE IS (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759634 TSS PRESS FIT STEM SZ. 10 TITAN TOTAL SHOULDER KWS ASCENSION ORTHOPEDICS 14-1955

    Patients

    Seq Age Sex Outcome Treatment
    1