BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOSPHERE 36MM SMALL-R

    MDR report key: 10941961 · Received December 3, 2020

    Report

    Report Number
    3008021110-2020-00108
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    November 13, 2012
    Report Date
    December 3, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE BECAME AWARE OF A SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2012 DUE TO IMPLANT INSTABILITY. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR GLENOSPHERE Ø36MM SMALL-R (PRODUCT CODE: (B)(4), LOT# 1204269 - STER. 1200166); SMR REVERSE LINER + 3 MM (PRODUCT CODE 1360.50.015, LOT# 1107249 - STER. 1100300). PRODUCT NOT MARKETED IN THE U.S. A 40 MM GLENOSPHERE, A CONNECTOR AND A 40 MM REVERSE LONG LATERALIZED LINER WERE IMPLANTED. THE IMPLANT WAS REVISED ON (B)(6) 2020: THE REVISION SURGERY WAS REGISTERED AS COMPLAINT#: (B)(4) (#(B)(4) LIMACORPORATE) AND REPORTED TO THE TGA. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2012. PATIENT IS A FEMALE. NO FURTHER INFORMATION AVAILABLE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405794 SMR GLENOSPHERE 36MM SMALL-R GLENOSPHERE - SMALL-R KWS LIMACORPORATE SPA 1374.09.105 1204269

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention