BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 30MM

    MDR report key: 2749781 · Received September 14, 2012

    Report

    Report Number
    9616680-2012-00769
    Event Type
    Injury
    Date Received
    September 14, 2012
    Date of Event
    August 27, 2012
    Report Date
    August 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS: MFR # 2249697-2012-01557.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF HIP PAIN AND AS SOON AS HE AND HIS LAWYERS SAW THE RECALL COMMERCIALS AND HE WANTED IT OUT. PULLED THE HEAD AND NECK AND SOME FRETTING AND METALLOSIS WAS OBSERVED UPON EXTRACTING THE NECK. ALSO FOUND SOME PUSS THAT LEAD DR. J TO BELIEVE HE MIGHT HAVE SOME INFECTION. LABS CAME BACK NEGATIVE SO A RESTORATION MODULAR WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 0DEG 30MM IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 34095802

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention