BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFORM HUMERAL STEM SZ 4 PLUS

    MDR report key: 15788316 · Received November 14, 2022

    Report

    Report Number
    0001649390-2022-00098
    Event Type
    Death
    Date Received
    November 14, 2022
    Date of Event
    October 14, 2022
    Report Date
    February 16, 2023
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    UDI-DI
    00846832085507
    PMA / PMN Number
    K201315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED IN PATIENT.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTION TO G1. THE EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER SURGICAL PROCEDURE. THE PATIENT EXPIRED FROM A BLOOD CLOT SOMETIME AFTER THE SURGERY. IT WAS REPORTED AS NOT DEVICE RELATED BUT PROBABLY PROCEDURE RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER SURGICAL PROCEDURE. THE PATIENT EXPIRED FROM A BLOOD CLOT SOMETIME AFTER THE SURGERY. IT WAS REPORTED AS NOT DEVICE RELATED BUT PROBABLY PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374616 PERFORM HUMERAL STEM SZ 4 PLUS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER INC DWX4PS AD5147029 00846832085507

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death