BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT- CERAMIC ON CERAMIC HIP

    MDR report key: 2234051 · Received August 29, 2011

    Report

    Report Number
    9616680-2011-00568
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT'S HUSBAND CALLED TO REPORT THAT HIS WIFE HAS A CERAMIC HIP AND HAS PAIN, THE HIP WAS SQUEAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT- CERAMIC ON CERAMIC HIP IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other