BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 1661822 · Received April 14, 2010

    Report

    Report Number
    2249697-2010-00402
    Event Type
    Injury
    Date Received
    April 14, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 17, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K062419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6260-9-240, LOT # MHLYE3, DESCRIPTION: V40 COCR LFIT HEAD 40MM/+4, CAT # NLV-340800G, LOT # 25519601, DESCRIPTION: LRG TAP PRI MOD NCK 8DEG 34MM. 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, "THOUGHT PATIENT HAD AN INFECTION. OPENED HIM UP AND WASHED OUT. SURGEON DID A HEAD AND LINER EXCHANGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT 40MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MJE4LT

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention