BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CTA HUMERAL HEAD Ø42 MM

    MDR report key: 9196369 · Received October 16, 2019

    Report

    Report Number
    3008021110-2019-00118
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    September 20, 2019
    Report Date
    October 16, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    HSD
    PMA / PMN Number
    K110847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHECK OF THE DHRS: BY CHECKING THE STERILIZATION CHARTS, NO ANOMALY WAS FOUND ON: 35 CEMENTLESS STEM MANUFACTURED WITH LOT#1806954 - STER. 1800219, 25 CTA HUMERAL HEAD MANUFACTURED WITH LOT#1609742 - STER. 1600202, 28 CTA ADAPTORS MANUFACTURED WITH LOT #1908258 - STER. 1900218. THEREFORE, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EVENT OCCURRED IN (B)(6). XRAYS/EXPLANTS ANALYSIS: IN ORDER TO PERFORM A DEEPER INVESTIGATION OF THIS CASE, WE REQUESTED PRE-OPERATIVE XRAYS TO THE COMPLAINT SOURCE BUT THEY WERE NOT AVAILABLE. CONCLUSION: AT THIS STAGE, IT IS NOT POSSIBLE TO PERFORM A DEEPER INVESTIGATION OF THIS CASE. STATING THAT: NO ANOMALY WAS FOUND BY THE CHECK OF THE STERILIZATION CHARTS. PATIENT WAS FOUND TO BE ALREADY INFECTED AT TIME OF THE CURRENT SURGERY. WE CAN SPECULATE THAT THIS EVENT IS NOT PRODUCT RELATED. 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, REVISION RATE DUE TO INFECTION OF SMR ANATOMIC HEMI SYSTEM IS 0.07%. NONE OF THESE INCIDENTS WAS PRODUCT RELATED. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET. PLEASE, CONSIDER THIS MDR AS A FINAL REPORT.

    Description of Event or Problem · 1

    POST-OPERATIVE ISSUE OCCURRED ON (B)(6) 2019 DUE TO INFECTION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2019. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT HAD PREVIOUS INFECTED CUFF REPAIR WHICH FAILED. AS PRIMARY SURGERY, CTA HEMI WAS IMPLANTED TO REPAIR FRACTURED GLENOID. HOWEVER, THE SAMPLES AT PRIMARY SURGERY WERE POSITIVE FOR INFECTION. THEREFORE, THE FOLLOWING IMPLANTS WERE REMOVED AND A CEMENT SPACER WAS THEN INSERTED: SMR CEMENTLESS FINNED STEM , COD. 1304.15.150, LOT #1806954, STER. 1800219, SMR CTA HUMERAL HEAD Ø42 MM , COD. 1323.09.420, LOT #1609742, STER. 1600202, SMR CTA HEADS ADAPTOR Ø36 MM , COD. 1352.15.200 , LOT #1908258, STER. 1900218. IT WAS REPORTED THAT BACTERIA MRSA WAS RESPONSIBLE FOR INFECTION. INVESTIGATION CHECK OF THE DHRS: BY CHECKING THE STERILIZATION CHARTS, NO ANOMALY WAS FOUND ON: 35 CEMENTLESS STEM MANUFACTURED WITH LOT#1806954 - STER. 1800219, 25 CTA HUMERAL HEAD MANUFACTURED WITH LOT#1609742 - STER. 1600202, 28 CTA ADAPTORS MANUFACTURED WITH LOT #1908258 - STER. 1900218. THEREFORE, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992999 SMR CTA HUMERAL HEAD Ø42 MM SMR CTA HUMERAL HEAD Ø42 MM (HSD-KWS) HSD LIMACORPORATE SPA 1323.09.420 1609742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention