BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 34MM NECK

    MDR report key: 2871950 · Received December 6, 2012

    Report

    Report Number
    9616680-2012-01337
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    October 24, 2011
    Report Date
    November 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED PAIN IN RIGHT LEG WITHIN THE LAST THREE MONTHS. PT DESCRIBED THE PAIN AS BEING IN THE FRONT THIGH AREA. PT IS ALSO EXPERIENCING PAIN IN HIS GROIN. PT STATED THAT HE HAS HAD HIS BLOOD WORK AND X-RAYS DONE AND THE RESULTS ARE PENDING. ADD'L INFO PROVIDED BY THE SALES REP INDICATES THAT THE SURGEON DID A REVISION ON PT'S RIGHT REJUVENATE RIGHT HIP BECAUSE, PT WAS EXPERIENCING PAIN AND PT HAD ELEVATED COBALT LEVELS AND AN MRI SHOWED A PSEUDO TUMOR. THE SURGEON REPLACED PT'S HIP WITH AN EXETER STEM, NEW LINER AND A FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN 34MM NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R