BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X45 ST

    MDR report key: 17906172 · Received October 10, 2023

    Report

    Report Number
    0001825034-2023-02345
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    September 26, 2023
    Report Date
    November 8, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02306-1, 0001825034-2023-02341-1, 0001825034-2023-02342-1, 0001825034-2023-02343-1, 0001825034-2023-02344-1, 0001825034-2023-02346-1. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SINGLE AP VIEW OF THE RIGHT SHOULDER DEMONSTRATES A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH MULTIPLE FRACTURE GLENOID SCREWS AND LOOSENING OF THE VRS IMPLANT FROM THE GLENOID. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 110027734, LOT: 65857128, COMPR VRS GLEN PPS MIN TPR ADR. CAT: 115399, LOT: UNKNOWN, COMP RVS CNTRL 6.5X45MM ST/RST. CAT: 180555, LOT: UNKNOWN, COMP LK SCR 3.5HEX 4.75X40 ST. CAT: 180556, LOT: UNKNOWN, COMP LK SCR 3.5HEX 4.75X45 ST (X3). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02306, 0001825034-2023-02341, 0001825034-2023-02342, 0001825034-2023-02343, 0001825034-2023-02344, 0001825034-2023-02346.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT VRS COMPONENT LOOSENED UPON IMPLANTATION AND THE SCREWS FRACTURED. NO REVISION HAS BEEN REPORTED TO DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290655 COMP LK SCR 3.5HEX 4.75X45 ST PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other SEE H10 NARRATIVE