BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID PEG TT SMALL-R #M

    MDR report key: 9201323 · Received October 17, 2019

    Report

    Report Number
    3008021110-2019-00120
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    October 9, 2019
    Report Date
    October 17, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHART OF THE INVOLVED LOT#S NO ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT#S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    INTRA-OPERITIVE ISSUE OCCURRED ON (B)(6) 2019. SURGEON WAS REMOVING THE LATERALIZED GLENOSPHERE FROM S/R TT BASEPLATE BECAUSE OF MALROTATION OF IMPLANTS. UPON REMOVAL OF GLENOSPHERE, THE BASEPLATE WITH SCREWS CODE 1375.15.605 LOT #1911768 STER. 1900299 DISASSOCIATED FROM TT PEG 1375.14.652 LOT #1912731 STER. 1900314 CREATING DEFECT ON PATIENT'S GLENOID. THE EVENT PROLONGED THE SURGERY OF 15 MINUTES. CONSEQUENTLY, THE PATIENT RECEIVED HEMI ARTHROPLASTY INSTEAD OF SCHEDULED RSA. CODES AND LOT #S OF THE USED INSTRUMENTS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999647 SMR GLENOID PEG TT SMALL-R #M SMR GLENOID PEG TT SMALL-R #M (KWS-KWT) KWS LIMACORPORATE SPA 1375.14.652 1912731

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization