BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 9161640 · Received October 7, 2019

    Report

    Report Number
    0001825034-2019-04391
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    October 14, 2019
    Report Date
    March 3, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : 115310 LOT 067720 GLENOSPHERE 36 MM STANDARD , 115370 LOT 041080 HUMERAL TRAY 44 MM STD , XL-115363 LOT 593370 HUMERAL BEARING 44MM 36MM STD.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS REVISED APPROXIMATELY THREE MONTHS POST-IMPLANTATION TO ADDRESS DISASSOCIATION OF THE GLENOSPHERE AND BASE PLATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED APPROXIMATELY THREE MONTHS POST-IMPLANTATION TO ADDRESS DISASSOCIATION OF THE ADAPTOR FROM THE BASE PLATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS BEING CONSIDERED FOR A REVISION TO ADDRESS DISASSOCIATION OF THE GLENOSPHERE AND BASE PLATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958464 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 463680

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other