BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32MM STD V40 TAPER VIT HEAD

    MDR report key: 3875229 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02301
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT CODE PROVIDED, 4711505, APPEARS TO BE INVALID. THE ACTUAL LOT WILL BE CONFIRMED UPON RECEIPT OF THE DEVICE AND THE UPDATED INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A BULGE ON THE INNER TYVEK INVOLVING PACKAGING FOR A METAL HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: THE DEVICE AND PACKAGING WERE RETURNED. THE SHRINK WRAP WAS NOT RETURNED. THE OUTER BOX WAS OPENED AND UNREMARKABLE. THE OUTER (B)(6) HAD BEEN PEELED BACK FROM THE INNER BLISTER ON 3 SIDES AND THERE WAS EVIDENCE OF A COMPLETE SEAL. THE INNER (B)(6) AND BLISTER WERE STILL SEALED. THERE WAS A SLIGHT BULGE OBSERVED ON THE CENTRE OF THE INNER (B)(6). THE EVENT WAS DISCUSSED WITH THE PACKAGING CELL, IT WAS DETERMINED THAT THE REPORTED EVENT DID NOT REPRESENT A NON-CONFORMANCE. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE OBSERVED BULGE ON THE (B)(6) WAS NOT A NON-CONFORMANCE.

    Description of Event or Problem · 1

    THE SALES REP, HAS REPORTED ON BEHALF OF THE CUSTOMER THAT A V40 HEAD HAS BEEN RECEIVED AND THE PACKAGE ALLEGEDLY LOOKS MOIST AND USED. THE CUSTOMER QUESTIONED IF THE PRODUCT IS STERILE. THE SALES REP REPORTED THAT ANOTHER V40 HEAD WAS USED.

    Description of Event or Problem · 1

    THE SALES REP, HAS REPORTED ON BEHALF OF THE CUSTOMER THAT A V40 HEAD HAS BEEN RECEIVED AND THE PACKAGE ALLEGEDLY LOOKS MOIST AND USED. THE CUSTOMER QUESTIONED IF THE PRODUCT IS STERILE. THE SALES REP REPORTED THAT ANOTHER V40 HEAD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352053 32MM STD V40 TAPER VIT HEAD IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH 4711505

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other