BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMR SHOULDER, FINNED STEM DIA. 22MM

    MDR report key: 3054849 · Received April 4, 2013

    Report

    Report Number
    3008021110-2012-00011
    Event Type
    Other
    Date Received
    April 4, 2013
    Date of Event
    August 18, 2012
    Report Date
    April 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

    THIS STEM WAS PACKAGED IN A DOUBLE VACUUMED POUCH. BY THE EVENT DESCRIPTION, AFTER OPENING THE OUTER VACUUMED POUCH, THE NURSE DETECTED THE DETERIORATION OF THE INNER VACUUMED POUCH WHICH CONTAINED THE SMR FINNED STEM. THE PACKAGING DHR OF THE BATCH INVOLVED DID NOT SHOW ANY ANOMALY. WE RECEIVED THE STEM AND THE PACKAGED, AND WE COULD VERIFY THE PRESENCE OF THE TEAR IN THE INNER VACUUMED POUCH. PROBABLY THE INNER POUCH LOST ITS "VACUUM", AND THE STEM STARTED HAVING MICRO-MOVEMENTS INSIDE THE POUCH, CAUSING THE TEAR IN THE INNER POUCH AND THE LOSS OF STERILITY OF THE DEVICE. LIMA CORPORATE RECEIVED 2 OTHER SIMILAR COMPLAINTS BEFORE THIS ONE, AND ALREADY PERFORMED THE FOLLOWING CORRECTIVE ACTION: INTRODUCTION OF AN ADDITIONAL OPA-PE POUCH (NOT VACUUMED) WHICH PHYSICALLY SEPARATES THE FINNED STEM FROM THE INNER VACUUMED POUCH. THIS SHOULD SIGNIFICANTLY REDUCE THE RISK OF RECURRENCE OF SUCH PACKAGING AND STERILITY ISSUE. 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

    DURING SURGERY, THE IMPLANT WAS REMOVED FROM THE CARDBOARD BOX BY THE NURSE OUTSIDE THE STERILE FIELD, AND WHEN SHE OPENED THE OUTER PLASTIC LAYER OF THE IMPLANT SHE NOTICED THAT THE INNER VACUUMED SEALED PLASTIC CONTAINING THE IMPLANT HAD BEEN COMPROMISED. THE PLASTIC APPEARS TO HAVE WORN THROUGH CAUSING A TEAR IN THE PLASTIC WRAPPER. THE IMPLANT NEVER ENTERED THE STERILE FIELD AS THE PACKAGING BREACH WAS IDENTIFIED BEFORE BEING TAKEN BY THE THEATRE SCRUB. THE DEVICE WITH THE PACKAGE WAS RETURNED TO LIMA CORPORATE. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139363 SMR SHOULDER, FINNED STEM DIA. 22MM KWT, HSD KWT LIMACORPORATE S.P.A. 1304.15.220 2010 07014

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A Hospitalization