BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL 9006

    MDR report key: 2760007 · Received September 20, 2012

    Report

    Report Number
    9616680-2012-00789
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K013106
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DEVICES IN STRYKER'S CONTROL FROM THE REPORTED LOT WERE CHECKED. IT WAS CONFIRMED THAT THE BOLT WAS PRESENT IN BOTH. HOWEVER, THE SALES REP WHO WAS PRESENT AT THE SURGERY CONFIRMED THAT THE BOLT WAS MISSING. THE REPORTED LOT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF CORRECTIVE ACTIONS TO ADDRESS THIS PACKAGING ISSUE. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT UPON OPENING OF THE PACKAGING DURING SURGERY, IT WAS OBSERVED THAT PART OF THE IMPLANT (THE BOLT) WAS MISSING FROM THE BOX AND ANOTHER DEVICE HAD TO BE OPENED AND WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 21MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL 9006 IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 26768401

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other