BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK

    MDR report key: 2231485 · Received July 22, 2011

    Report

    Report Number
    9616680-2011-00491
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K023901
    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.

    Description of Event or Problem · 1

    THE SALES REP REPORTED ON BEHALF OF THE CUSTOMER, THAT THE V40 ALUMINA CERAMIC HEAD WOULD NOT FIT ONTO THE V40 EXETER STEM AND IT APPEARED THAT THE TAPERS WERE INCOMPATIBLE. THE SALES REP FURTHER REPORTED THAT ANOTHER HEAD WAS IMMEDIATELY AVAILABLE. THEREFORE, THERE WERE NO DELAYS TO SURGERY AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 35226701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other