BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 15649328 · Received October 21, 2022

    Report

    Report Number
    3008021110-2022-00098
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 27, 2022
    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 DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE STEMS RELEASED WITH LOT NUMBER 1810263, STER. 1800254. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON LOT NUMBER 1810263. WE WILL SUBMIT A FINAL REPORT AFTER THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE STEMS RELEASED WITH LOT NUMBER 1810263, STER. (B)(4). THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON LOT NUMBER 1810263. FOLLOWING THE VISUAL INSPECTION OF THE RETRIEVED 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 FROM 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 0.01%.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED ON THE (B)(6) OF (B)(6) 2022 DURING SHOULDER SURGERY: THE PACKAGING OF THE SMR CEMENTLESS FINNED STEM WITH PRODUCT CODE 1304.15.200, LOT 1810263, STER. 1800254, WAS FOUND DAMAGED. ANOTHER STEM (CEMENTED STEM 1306.15.200) WAS THEREFORE IMPLANTED AND THE SURGERY WAS POSITIVELY COMPLETED WITH FEW MINUTES OF DELAY. THIS EVENT OCCURRED IN FRANCE.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED ON THE (B)(6) 2022 DURING SHOULDER SURGERY: THE PACKAGING OF THE SMR CEMENTLESS FINNED STEM WITH PRODUCT CODE 1304.15.200, LOT 1810263, STER. (B)(4), WAS FOUND DAMAGED. ANOTHER STEM (CEMENTED STEM (B)(4)) WAS THEREFORE IMPLANTED, AND THE SURGERY WAS POSITIVELY COMPLETED WITH FEW MINUTES OF DELAY. THIS EVENT OCCURRED IN FRANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557884 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM HSD LIMACORPORATE S.P.A. 1304.15.200 1810263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization