BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS. HIP ENDOPROSTHESIS

    MDR report key: 1981621 · Received January 12, 2011

    Report

    Report Number
    9616680-2010-00862
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 14, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PACKAGING WAS DAMAGED. THE CUSTOMER FURTHER REPORTED THAT THE OUTER BOX WAS FINE BUT WHEN OPENED THE INNER PACKAGING WAS DAMAGED. THE CUSTOMER ADDED THAT HE BELIEVES THIS MAY COMPROMISE THE STERILITY OF THE PRODUCT. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS. HIP ENDOPROSTHESIS IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA G3040133

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other