BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 2171334 · Received July 15, 2011

    Report

    Report Number
    2249697-2011-01061
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6265-5107, LOT# 1823B902, DESCRIPTION: CITATION TMZF HA STEM #7 LEFT. CAT # 509-02-66H, LOT # OL6MJA, DESCRIPTION: TRITANIUM REVISION ACETABULAR. CAT # 6260-9-240, LOT # 931MAD, DESCRIPTION: V40 COCR LFIT HEAD 40MM/+4. 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, "THE PATIENT HAD A STAPH INFECTION. THE IMPLANT WAS REMOVED AND A SPACER WAS IMPLANTED FOR SIX WEEKS. LAST WEEK THE PATIENT WAS REVISED AND IS NOW IN REHAB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT 40MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA E99MMA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| O| R