BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM REVISION ACETABULAR

    MDR report key: 2070913 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00522
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K010170
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 # 64951001, LOT # SNENJ, DESCRIPTION: PROXIMAL FEM COMP STD. CAT # 6495-5-218, LOT # LLYNW, DESCRIPTION: 18MM PRESS FIT BOWED STEM 150. CAT # 6260-9-444, LOT # P84MAO, DESCRIPTION: V40 COCR LIFT HEAD 44MM +12. CAT # 623-00-44H, LOT # MJHTAW, DESCRIPTION: TRIDENT 0 DEG INSERT 44MM. 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: "PATIENT HAD CHRONIC INFECTION IMPLANTS WERE REMOVED AND ANTI-BIOTIC SPACERS WERE IMPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRITANIUM REVISION ACETABULAR IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA PN4MNE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R