BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 16231453 · Received January 24, 2023

    Report

    Report Number
    3008021110-2023-00003
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    January 10, 2023
    Report Date
    January 23, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE PACKAGING CYCLES, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE STEMS THAT BELONG TO THE SAME LOT NUMBER (1906857, STER. 1900244). THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THIS LOT NUMBER. A FINAL REPORT WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE PACKAGING CYCLES, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE STEMS THAT BELONG TO THE SAME LOT NUMBER (1906857, STER. 1900244). ACCORDING TO OUR RECORDS, AT LEAST 57 STEMS WITH LOT NUMBER 1906857, STER. 1900244 HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THIS LOT NUMBER. FOLLOWING THE VISUAL INSPECTION OF THE AFFECTED PACKAGING, THE TYPE OF DAMAGES OBSERVED MAKES US BELIEVE THAT THEY COULD BE RELATED TO AN INCORRECT HANDLING OF THE DEVICE AND/OR AS A CONSEQUENCE OF A FALL OR IMPACT: IT IS VERY UNLIKELY THAT THESE DAMAGES MAY HAVE OCCURRED DURING STANDARD TRANSPORT/STORAGE. STATING THAT: - BY THE CHECK OF THE PRODUCTION DOCUMENTS, NO PRE-EXISTING ANOMALIES WERE IDENTIFIED - LIMACORPORATE IS NOT AWARE OF ANY OTHER COMPLAINT ON THE SAME PRODUCTION OR STERILIZATION LOT NUMBERS - THE DAMAGES OBSERVED SUGGEST THEY MAY HAVE BEEN CAUSED BY MISHANDLING OF THE DEVICE WE CONCLUDE THAT THE PACKAGING ISSUE REPORTED IS PROBABLY RELATED TO EXTERNAL FACTORS SUCH AS INCORRECT HANDLING OF THE ITEM. WE WOULD LIKE TO SPECIFY THAT THE INDICATIONS PROVIDED BY THE MANUFACTURER, REPORTED ON THE PACKAGING, ON THE INSTRUCTION FOR USE AND ON THE ENVELOPES THEMSELVES, CLEARLY SPECIFY THAT THE DEVICE MUST NOT BE USED IF THE PACKAGE IS DAMAGED OR THE VACUUM ON THE ENVELOPES IS NO LONGER PRESENT: IN CASE OF BROKEN PACKAGES, THE ITEM MUST NOT BE USED ON A PATIENT. BASED ON LIMACORPORATE PMS DATA AND CONSIDERING THE SMR STEMS WITH CODES 1304.15.XXX, PACKAGED WITH THE MOST RECENT VERSION OF THE PACKAGING (I.E. INTERNAL PA POUCH + 2 VACUUMED POUCHES + BOXES WITH PROTECTIVE SPONGES, INTRODUCED IN 2016), WE CAN ESTIMATE AN OCCURRENCE RATE OF THIS KIND OF INTRA-OPERATIVE ISSUE OF ABOUT (B)(4). NO CORRECTIVE ACTIONS NEEDED FOLLOWING THIS COMPLAINT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    INTRAOPERATIVE ISSUE OCCURRED ON (B)(6) 2023, DURING SHOULDER SURGERY: THE PACKAGE OF THE SMR STEM WITH CODE 1304.15.220 AND LOT NUMBER 1906857, STER. 1900244, WAS FOUND DAMAGED. THE STEM WAS NOT USED AND A SMALLER ONE HAD TO BE IMPLANTED. THE ISSUE CAUSED 5 MINUTES OF PROLONGED SURGERY TIME. THIS EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    INTRAOPERATIVE ISSUE OCCURRED ON (B)(6) 2023, DURING SHOULDER SURGERY: THE PACKAGE OF THE SMR STEM WITH CODE 1304.15.220 AND LOT NUMBER 1906857, STER. 1900244, WAS FOUND DAMAGED. THE STEM WAS NOT USED AND A SMALLER ONE HAD TO BE IMPLANTED. THE ISSUE CAUSED 5 MINUTES OF PROLONGED SURGERY TIME. THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301878 SMR CEMENTLESS FINNED STEM SMR CEMENTLESS FINNED STEM HSD LIMACORPORATE S.P.A. 1304.15.220 1906857

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization