BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM

    MDR report key: 1900043 · Received November 9, 2010

    Report

    Report Number
    2249697-2010-01494
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 14, 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
    ND, 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. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6021-0335, LOT# 27013703, DESCRIPTION: ACCOLADE PLUS TMZF HIP STEM #3. CAT # 623-00-36D, LOT # MHDRR9, DESCRIPTION: TRIDENT 0 DEG INSERT 36MM. CAT # 6209-9-136, LOT# 006MNE, V40 COCR LIFT HEAD 36MM/0. IT CANNOT BE DETERMINED WHICH, IF ANY, OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT COMPLAINED OF PAIN. BLOOD WORK SHOWED INFECTION. MRI SHOWED LOOSE CUP. CUP REMOVED AND STEM REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MHD208

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R