BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALUMINA CERAMIC INSERT TYPE 32/41

    MDR report key: 2143486 · Received June 2, 2011

    Report

    Report Number
    9616680-2011-00366
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    IT WAS REPORTED THAT DURING A SURGERY (HIP REDUCTION), THE CERAMIC INSERT FRACTURED. THE SURGEON USED ANOTHER IMPLANT TO FINISH THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA CERAMIC INSERT TYPE 32/41 IMPLANT MRA STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other