BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM. CUP W/HA

    MDR report key: 1962690 · Received January 10, 2011

    Report

    Report Number
    9616680-2011-00022
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 29, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K072020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHEN THE IMPLANT WAS OPENED THE SURGEON ATTEMPTED TO IMPACT IT. DURING IMPACTION, PT POSTERIOR WALL FRACTURE COULDN'T GET THE CUP TO BITE. THEY DECIDED TO PUT A TRITANIUM CUP WITH SCREWS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION ADM. CUP W/HA IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G2937171

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention