BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM REVERSE GLENOSPHERE HEAD

    MDR report key: 8805440 · Received July 18, 2019

    Report

    Report Number
    0001822565-2019-03070
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 26, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K121543
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. X-RAYS IDENTIFIED DISASSEMBLY OF THE LEFT SHOULDER WITH THE GLENOSPHERE SEPARATING FROM THE BASEPLATE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. UDI: (B)(4).

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00-4349-015-00, TM RVS BASE PLT 15MM POST +0, 64227255, 00434903600, POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER, 63953120. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-03101. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SHOULDER WAS REVISED APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO DECOUPLING OF GLENOSPHERE FROM THE BASE PLATE. DURING REVISION ONLY THE GLENOSPHERE COMPONENT WAS REPLACED. THE BASE PLATE COMPONENT WAS NOT REMOVED FROM THE PATIENT BECAUSE IT WAS FIRMLY POSITIONED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597065 TM REVERSE GLENOSPHERE HEAD PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 64258265

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R