BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM

    MDR report key: 1622438 · Received February 19, 2010

    Report

    Report Number
    2249697-2010-00184
    Event Type
    Other
    Date Received
    February 19, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DHR, COMPLAINT HISTORY, PACKAGING INSERT AND SURGICAL TECHNIQUE REVIEW. EVALUATION SUMMARY: AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. THE DEVICE MANUFACTURING HISTORY RECORD INDICATES NO REPORTED DISCREPANCIES. THE PRODUCT EXPERIENCE REPORTING DATABASE SHOWS THAT THERE HAVE BEEN NO OTHER REPORTED EVENTS REGARDING THE REPORTED DEVICE LOT CODES. THE RESULTS OF THE INVESTIGATION PERFORMED INDICATED THAT THE USE OF THE TRIDENT ALUMINA INSERT WITH PRIMARY TRITANIUM HEMISPHERICAL CLUSTER SHELL WAS CONTRAINDICATED FROM THE TRITANIUM PRIMARY SURGICAL PROTOCOL AND PRODUCT IFU. THE TRITANIUM SURGICAL PROTOCOL (LSP66 REVISION 1) WAS REVIEWED AND ON PAGE 2, THE COMPATIBILITY CHART DOES NOT INDICATE THAT A TRIDENT ALUMINA INSERT CAN BE USED WITH THE PRIMARY TRITANIUM HEMISPHERICAL CLUSTER SHELL. ADDITIONALLY, THE SHELL TO INSERT COMPATIBILITY SECTION OF THE LATEST REVISION OF PRODUCT IFU (QIN 4397 REVISION E) STATES: "TRITANIUM SHELLS (500-03-XXX, 502-03-XXX, 500-13-XXX AND 502-13-XXX) CAN BE USED WITH TRIDENT POLYETHYLENE INSERTS AND ARE NOT APPROVED FOR USE WITH TRIDENT CERAMIC INSERTS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "OFF LABEL PRODUCT USAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MHJPWM

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other