BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 38MM

    MDR report key: 2915574 · Received January 10, 2013

    Report

    Report Number
    9616680-2013-90074
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS EXPERIENCING DIFFICULTIES WITH THEIR HIP IMPLANT AND HAS HAD BLOOD TESTS AND MRI. THE PT HAD AN ELEVATED ION BLOOD COUNT AND COMPLAINED OF PAIN. DR (B)(6) REVISED THE FEMORAL STEM WITHOUT MUCH DIFFICULTY AND IMPLANTED SECURE FIT IMPLANTS TO MATCH UP WITH APPROPRIATE CUP LEG LENGTH. HE ALSO PLACED A CABLE AROUND THE PROXIMAL STEM. HER CHROMIUM LEVEL WAS 8.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15191 LRG TAP PRI MOD NCK 0DEG 38MM IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA 26583201

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention