BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 8627569 · Received May 21, 2019

    Report

    Report Number
    3008021110-2019-00060
    Event Type
    Injury
    Date Received
    May 21, 2019
    Report Date
    April 24, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    UDI-DI
    08033390002554
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT#S NO PRE - EXISTING ANOMALY WAS FOUND. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    PRIMARY SHOULDER REVERSE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2018. SINCE THE PRIMARY SURGERY TOOK PLACE, THE PATIENT HAS BEEN SUFFERING OF SWELLING AND PUS OF UNKNOWN CAUSE. TEST RESULTED TO BE NEGATIVE FOR EXPOSURE TO BACTERIA AND INFECTION SOURCE HAS NOT BEEN IDENTIFIED YET. IT HAS BEEN REPORTED THAT PROBABLY THE PATIENT IS ALLERGIC TO METAL. REVISION SURGERY WILL BE PERFORMED AS SOON A SOLUTION FOR THE PATIENT WILL BE DEFINE. THE COMPONENT IMPLANTED DURING THE PRIMARY SURGERY ARE THE FOLLOWING: SMR CEMENTLESS FINNED STEM, CODE 1304.15.160, LOT #1800893, STER. 1800107. SMR REVERSE HUMERAL BODY, CODE 1352.15.010, LOT #1802167, STER. 1800073. SMR REVERSE LINER + 3 MM, CODE 1360.50.015, LOT #17AT25U, STER. 1800011. SMR METAL-BACK GLENOID SMALL R, CODE 1375.21.005, LOT #1801431, STER. 1800073. SMR GLENOSPHERE Ø36MM SMALL-R, CODE 1376.09.025, LOT #1704993, STER. 1700150. BONE SCREW Ø6,5 H.25MM, CODE 8420.15.020, LOT #1714960, STER. 1800028. BONE SCREW Ø6,5 H.40MM, CODE 8420.15.050, LOT #1518227, STER. 1500396. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421489 SMR SHOULDER ECCENTRICAL GLENOSPHERE - SMALL-R KWS LIMACORPORATE S.P.A. ECCENTRICAL GLENOSPHERE 1704993 08033390002554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention