BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 8DEG 34MM

    MDR report key: 2780701 · Received October 4, 2012

    Report

    Report Number
    9616680-2012-00845
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. A REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOTS. THE PRODUCT EXPERIENCE REPORTING DATABASE SHOWS THERE HAVE BEEN NO OTHER EVENTS FOR ANY OF THE REPORTED LOTS. THE ROOT CAUSE COULD NOT BE DETERMINED WITH THE LIMITED INFO AVAILABLE AT THE TIME OF THE EVAL. THIS IS THE SAME PT / EVENT AS MFR #2249697-2012-00867.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT IS HAVING DIFFICULTY WITH FLEXION AND ABDUCTION WITH PAIN ACROSS THE THIGH. THE PROBLEMS BEGAN IN (B)(6) 2012 AND ARE GETTING PROGRESSIVELY WORSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 8DEG 34MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 35286802

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention