BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 16303341 · Received February 6, 2023

    Report

    Report Number
    3008021110-2023-00010
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 23, 2023
    Report Date
    February 6, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO OTHER SIMILAR COMPLAINT WAS REGISTERED ON THE SMR STEMS 1304.15.220 WITH LOT NUMBER 1303788 AND STER. 2000074. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED (1303788 STER. (B)(4)). THIS IS THE FIRST AND ONLY SIMILAR COMPLAINT REGISTERED ON THIS LOT NUMBER (1303788 STER. (B)(4)). 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

    INTRA-OPERATIVE ISSUE OCCURRED ON (B)(6) 2023: DURING SHOULDER SURGERY, THE PACKAGE OF THE SMR STEM WITH CODE 1304.15.220, LOT 1303788 STER. 2000074 WAS FOUND DAMAGED. THE SURGERY WAS COMPLETED WITH A DIFFERENT HUMERAL STEM AND THE ISSUE CAUSED 5-10 MINUTES OF DELAY. THIS EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED ON (B)(6) 2023: DURING SHOULDER SURGERY, THE PACKAGE OF THE SMR STEM WITH CODE 1304.15.220, LOT 1303788 STER. (B)(4) WAS FOUND DAMAGED. THE SURGERY WAS COMPLETED WITH A DIFFERENT HUMERAL STEM AND THE ISSUE CAUSED 5-10 MINUTES OF DELAY. THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108311 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.22MM HSD LIMACORPORATE S.P.A. 1304.15.220 1303788

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization