BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID BASEPLATE SMALL-R

    MDR report key: 9138660 · Received October 1, 2019

    Report

    Report Number
    3008021110-2019-00111
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    September 12, 2019
    Report Date
    October 1, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHECK OF THE DHRS: BY CHECKING THE STERILIZATION CHARTS OF THE LOT#/STER. INVOLVED, NO ANOMALY WAS FOUND: ON A TOTAL OF 20 SMR CONNECTOR SMALL R MANUFACTURED WITH LOT #1809753/STER.1800209, ON A TOTAL OF 59 SMR GLENOID PEG TT SMALL-R #L MANUFACTURED WITH LOT #1802842/STER.1800073, ON A TOTAL OF 23 SMR GLENOID BASEPLATE SMALL-R MANUFACTURED WITH LOT #1800756/STER.1800073. NO ANOMALY WAS FOUND ON THE ALL COMPONENTS MANUFACTURED WITH LOT#/STER. INVOLVED. THEREFORE, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. STATING THAT: NO ADDITIONAL INFORMATION RELATED TO PATIENT CONDITIONS, NO X-RAY IMAGES, NO EXPLANTED COMPONENT. WERE PROVIDED BY THE COMPLAINT SOURCE TO THE MANUFACTURER, THERE IS NO POSSIBILITY TO PERFORM A DEEPER INVESTIGATION AT THIS STAGE. NO CERTAIN ROOT CAUSE CAN BE ESTIMATED FOR THIS CASE BUT, BASED ON THE CHECK OF THE STERILIZATION CHARTS PERFORMED WE CAN SPECULATE INFECTION WAS NOT PRODUCT RELATED. PLEASE, CONSIDER THE CURRENT REPORT AS A COMBINED INITIAL-FINAL MDR. SHOULD WE RECEIVE ADDITIONAL INFORMATION IN THE FUTURE, WE WILL PROVIDE AN UPDATED FINAL INCIDENT REPORT ABOUT THIS CASE. PMS DATA: ACCORDING TO OUR PMS DATA, THIS IS THE FIRST AND ONLY COMPLAINT DUE TO INFECTION OUT OF MORE THAN 2200 SMR STEMLESS REVERSE SYSTEMS IMPLANTED SINCE 2014, WITH A REVISION RATE OF 0.04%. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 1

    REVISION SURGERY OF SMR STEMLESS REVERSE DUE TO INFECTION PERFORMED ON(B)(6) 2019. ACCORDING TO THE INFO REPORTED, SWAB TEST SHOWED PRESENCE OF P.ACNES BACTERIA. ALL THE FOLLOWING COMPONENTS WERE REMOVED AND SPACER WAS IMPLANTED: SMR STEMLESS - REV. LINER #S NOT MARKED IN USA SMR STEMLESS - STEML. CORE #S NOT MARKED IN USA SMR CONNECTOR SMALL R CODE 1374.15.305 LOT #1809753 STER.1800209 SMR REVERSE HP GLENOSPH. 40 MM NOT MARKED IN USA SMR GLENOID PEG TT SMALL-R #L CODE 1375.14.653 LOT #1802842 STER.1800073 SMR GLENOID BASEPLATE SMALL-R CODE 1375.15.605 LOT #1800756 STER.1800073. PRIMARY SURGERY WAS DUE TO CUFF FAILURE AND WAS PERFORMED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WERE RECEIVED BY THE COMPLAINT SOURCE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934416 SMR GLENOID BASEPLATE SMALL-R SMR GLENOID BASEPLATE SMALL-R (KWS-KWT ) KWS LIMACORPORATE SPA 1375.15.605 1800756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention