BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA 58MM LO.PRO CLUSTER SHELL

    MDR report key: 1753911 · Received July 8, 2010

    Report

    Report Number
    2249697-2010-00806
    Event Type
    Injury
    Date Received
    July 8, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K894149
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE ABOVE IMPLANTS WERE IMPLANTED IN THE (B) (6) IN (B) (6). PREVIOUS SURGERY DATE AND OP REPORT WERE UNAVAILABLE. THE ABOVE IMPLANTS WERE EXPLANTED DUE TO ACETABULAR SHELL LOOSENING AND ACETABULAR OSTEOLYSIS. THE STYKER HOWMEDICA MERIDIAN FEMORAL STEM WAS WELL FIXED AND WAS LEFT IN PLACE. THE FOLLOWING WERE IMPLANTED: 509-02-62G (B) (4) TRITANIUM SHELL 62MM, 2080-0030 (B) (4) SCREW, 2080-0020 (B) (4) SCREW, 623-10-36G (B) (4) X336MM 10 DEG INSERT, (B) (4) V40 / C-TAPER SLEEVE, 18-3675 (B) (4) BIOLOX 36MM + 7.5 CTAPER HEAD, AND 6184-1-015 (B) (4) HYDROSET AROUND THE PROXIMAL FEMORAL STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA 58MM LO.PRO CLUSTER SHELL IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA CBMID

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R