BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMR HUMERAL HEAD DIA. 46MM

    MDR report key: 3704375 · Received March 5, 2014

    Report

    Report Number
    3008021110-2014-00002
    Event Type
    Other
    Date Received
    March 5, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 7, 2014
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE WORK CYCLE OF THE HUMERAL HEAD INVOLVED, WITHOUT FINDING ANY ANOMALY DURING THE PACKAGING PHASES OF THE DEVICE. A TOTAL OF 49 HUMERAL HEADS HAVE BEEN PACKAGED WITH THE LOT # 201110126-1200007. ALSO, WE KNOW THAT 48 HUMERAL HEADS WITH THE ABOVE LOT NUMBER HAVE BEEN IMPLANTED, AND WE DID NOT RECEIVE ANY SIMILAR SIGNALING. WE WILL RECEIVE THE PACKAGE, AND WE WILL SUBMIT A FOLLOW-UP MDR AFTER ANALYSIS ON IT.

    Description of Event or Problem · 1

    BY THE INFO RECEIVED, THERE WAS A PACKAGING ISSUE WITH A SMR HUMERAL HEAD DURING A SURGERY DATED (B)(6) 2014. THIS DEVICE IS PACKAGED INTO A DOUBLE (OUTER AND INNER) VACUUMED POUCH. IN DETAIL, IT SEEMS THAT THE HUMERAL HEAD DROPPED OUT FROM THE INNER VACUUMED POUCH BEFORE OPENING IT, AS IF THE INNER POUCH WAS NOT SEALED. THE SURGERY HAS BEEN COMPLETED WITHOUT PROBLEMS, BY USING ANOTHER SIZE OF HUMERAL HEAD AVAILABLE IN SURGICAL ROOM. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133347 SMR HUMERAL HEAD DIA. 46MM KWT, HSD KWT LIMACORPORATE S.P.A. 1322.09.460 201110126-1200007

    Patients

    Seq Age Sex Outcome Treatment
    1