BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMR SHOULDER, FINNED STEM DIA. 22MM

    MDR report key: 3430342 · Received October 3, 2013

    Report

    Report Number
    3008021110-2013-00021
    Event Type
    Other
    Date Received
    October 3, 2013
    Date of Event
    August 22, 2013
    Report Date
    October 3, 2013
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K101263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE DHR RELATED TO THE PACKAGING PROCESS OF THIS STEM (BATCH 201005442-1000208), WITHOUT FINDING ANY ANOMALY. BY THE EVENT DESCRIPTION, WE KNOW THAT THE STEM LOST ITS "VACUUM" AND STARTED HAVING MICRO-MOVEMENTS WITHIN THE BOX. WE BELIEVE THAT THIS COULD HAVE BEEN CAUSED BY BAD HANDLING / UNEXPECTED BUMPS EXPERIENCED BY THE BOX DURING THE TRANSPORTATION PHASES OF THE DEVICE FROM ITALY TO AUSTRALIA. IT'S LIKELY THAT WE WILL RECEIVE THE PACKAGE OF THE STEM, WE WILL SUBMIT A FOLLOW-UP REPORT AFTER ANALYZING THE PACKAGE. THE STEM INVOLVED IN THIS PACKAGING SIGNALING WAS PACKAGED INTO A DOUBLE VACUUMED POUCH. TO REDUCE THE RISK OF RECURRENCE OF SUCH ISSUE LIMACORPORATE ALREADY PERFORMED THE FOLLOWING CORRECTIVE ACTION: INTRODUCTION OF AN ADDITIONAL PROTECTIVE OPA-PE POUCH (NOT VACUUMED) WHICH PHYSICALLY SEPARATES THE FINNED STEM FROM THE INNER VACUUMED POUCH. THIS SHOULD AVOID THE UNINTENTIONAL DAMAGE OF THE INNER AND OUTER VACUUMED POUCH. ALL THE SMR FINNED STEMS WHICH REACH THE US MARKET ARE PACKAGED IN THIS TRIPLE POUCH AND, UNTIL NOW, WE DID NOT RECEIVE INFORMATION ON SIMILAR ISSUES WITH TRIPLE-PACKAGED SMR STEMS.

    Description of Event or Problem · 1

    THIS IS A SIGNALING REGARDING THE PACKAGING OF A SMR STEM, THE EVENT OCCURRED IN (B)(6). DURING SURGERY, THE IMPLANT PACKAGING HAS BEEN FOUND TO BE COMPROMISED; THE PLASTIC WRAPPING HAS HOLES WORN IN IT DUE TO MOVEMENT OF THE STEM WITHIN THE INNER AND OUTER POUCH, SO THE STERILITY OF THE DEVICE WAS NOT ENSURED. THERE WAS A 2ND ITEM IN THE HOSPITAL THAT THE SURGEON WAS ABLE TO USE FOR THE CASE, SO THERE WAS NO IMPACT ON THE SURGERY TIME OR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501329 SMR SHOULDER, FINNED STEM DIA. 22MM KWT, HSD KWT LIMACORPORATE S.P.A. 1304.15.220 201005442-1000208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization