BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR ECC.ADAPTOR TAPER STANDARD

    MDR report key: 9231451 · Received October 24, 2019

    Report

    Report Number
    3008021110-2019-00122
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    October 12, 2019
    Report Date
    October 23, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHECK OF THE DHR: BY CHECKING THE STERILIZATION CHARTS OF THE LOT# INVOLVED, NO ANOMALY WAS FOUND ON: A TOTAL OF (B)(4) SMR CEMENTLESS FINNED STEM MANUFACTURED WITH LOT #1904967, STER.1900169. A TOTAL OF (B)(4) SMR HUMERAL HEAD MANUFACTURED WITH LOT #1904857, STER.1900158. A TOTAL OF (B)(4) SMR ECC.ADAPTOR MANUFACTURED WITH LOT #1805124, STER.1800153. A TOTAL OF (B)(4) SMR TRAUMA HUM. BODY MANUFACTURED WITH LOT #1809688, STER.1800239. THEREFORE, WE CAN STATE ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    FIRST STAGE REVISION SURGERY OF A SMR HEMI PROSTHESIS PERFORMED ON (B)(6) 2019 DUE TO WOUND INFECTION. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019 AND WAS DUE TO TRAUMA (SURGEON RESPONSIBLE FOR PRIMARY SURGERY WAS NOT THE SURGEON RESPONSIBLE FOR THE FIRST STAGE REVISION) . IT WAS FOUND THAT BACTERIA RESPONSIBLE FOR INFECTION WAS (B)(6). ON (B)(6) 2019 WASH OUT WAS PERFORMED, BUT THEN IT WAS DECIDED TO REMOVE ALL THE FOLLOWING IMPLANTS: 1304.15.190, SMR CEMENTLESS FINNED STEM, LOT #1904967, STER.1900169, 1322.09.501, SMR HUMERAL HEAD D.50 H.16MM, LOT #1904857, STER.1900158, 1330.15.274, SMR ECC.ADAPTOR TAPER STANDARD, LOT #1805124, STER.1800153, 1350.15.010, SMR TRAUMA HUM. BODY # MEDIUM, LOT #1809688, STER.1800239. ACCORDING TO THE INFO REPORTED, ANTIBIOTIC CEMENT WAS USED DURING THIS STAGE REVISION. NO OTHER INFORMATION AVAILABLE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027071 SMR ECC.ADAPTOR TAPER STANDARD SMR ECC.ADAPTOR TAPER STANDARD (KWT, HSD) KWT LIMACORPORATE SPA 1330.15.274 1805124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention