BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 44MM

    MDR report key: 1942441 · Received December 22, 2010

    Report

    Report Number
    2249697-2010-01848
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K062419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF ADD'L INFO BECOMES AVAILABLE, THEN, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 542-11-56F, LOT # 34170101, DESCRIPTION: TRIDENT PSL HA CLUSTER 56MM. CAT # 5353-0-118, LOT # 27008702, DESCRIPTION: CENTPILLAR TMZF SIZE 8 RIGHT. CAT # 6260-9-244, LOT # MJEJ4E, DESCRIPTION: V40 COCR LFIT HEAD 44MM/+4. 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, "THE PT HAD A THA ON (B)(6) 2010. RECENTLY, THE PT WAS INFECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT 44MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MJLEEE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R