BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA C-TAPER EHAD 36MM/+5

    MDR report key: 2090900 · Received May 12, 2011

    Report

    Report Number
    9616680-2011-00287
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K971409
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD EXPERIENCED A FALL APPROXIMATELY 6 MONTHS EARLIER AND COMPLAINED OF PAIN AND GRINDING IN HIS CERAMIC/CERAMIC HIP WHICH WAS IMPLANTED IN 2005. PAIN WAS SEVERE ENOUGH THAT PT WANTED A REVISION. UPON EXPLORATION AND REMOVAL OF LINER, SCREW AND HEAD, IT WAS NOTED THAT NOTHING APPEARED WRONG OR UNUSUAL WITH IMPLANTS. NO STRIPE WEAR, NO PARTICLES, THE IMPLANTS LOOKED FINE. SURGEON REPLACED CERAMIC AND HEAD WITH A POLY 40MM LINER AND A PLUS 5MM METAL HEAD. IMPLANTS WERE REQUESTED TO KEEP BY PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA C-TAPER EHAD 36MM/+5 IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 10020901

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention