BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQ REV II GLENOID BASEPLATEDIA 25 MM

    MDR report key: 13114645 · Received December 29, 2021

    Report

    Report Number
    3000931034-2021-00364
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 6, 2021
    Report Date
    March 22, 2022
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    PMA / PMN Number
    K081059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE REFER TO D9/H3 - DEVICE NOT RETURNED, H6 DEVICE CODE. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. REPORTED LOT AND REFERENCE NUMBERS OF THE SPHERES, SHOWED THAT THE TWO SPHERES USED WERE DIFFERENT AND WERE COMPATIBLE WITH THE FIRST BASEPLATE USED. THERE WAS NO SIMILAR COMPLAINT REPORTED WITHIN THE SAME BASEPLATE LOT NUMBER. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER 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 IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS CURRENTLY BEING RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    NO CONNECTION/ENGAGEMENT BETWEEN BASEPLATE AND GLENOSPHERE DURING OPERATION. MULTIPLE GLENOSPHERES OPENED BUT STILL NO ENGAGEMENT SO DECISION MADE TO REVISE BASEPLATE. ONCE BASEPLATE REVISED, GLENOSPHERE ENGAGED EASILY.

    Description of Event or Problem · 0

    NO CONNECTION/ENGAGEMENT BETWEEN BASEPLATE AND GLENOSPHERE DURING OPERATION. MULTIPLE GLENOSPHERES OPENED BUT STILL NO ENGAGEMENT SO DECISION MADE TO REVISE BASEPLATE. ONCE BASEPLATE REVISED, GLENOSPHERE ENGAGED EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010731 AEQ REV II GLENOID BASEPLATEDIA 25 MM SHOULDER JOINT METAL PROSTHESIS KWS TORNIER S.A.S. AD7675

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown