BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM

    MDR report key: 1837628 · Received September 14, 2010

    Report

    Report Number
    2249697-2010-01207
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 18, 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
    AR, 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 ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 2030-6520-1, LOT # MHPLJL, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 20MM. CAT # 2030-6535-1, LOT # MHNKJA, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 35MM. CAT # 643-00-36E, LOT # MHPK71, DESCRIPTION: TRIDENT X3 ELEVATED RIM 36MM ID. CAT # 6054-0812S, LOT # MHDTR6, DESCRIPTION: SECUR-FIT PLUS-MAX. CAT # 06-3605, LOT # 43PMLD, DESCRIPTION: C-TAPER COCR LFIT HEAD 36MM/+5. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES, MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "INFECTED TOTAL HIP. RESECTION OF THE TOTAL HIP ARTHROPLASTY. CEMENT SPACER PUT IN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MHL19W

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R