BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 34MM

    MDR report key: 2831091 · Received November 2, 2012

    Report

    Report Number
    9616680-2012-00984
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PT FOR HIS LAW FIRM AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS: MFR # 2249697-2012-02189 & MFR # 9616680-2012-00985.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PT REPORTED PAIN IN RIGHT HIP, DR. (B)(6) PERFORMED ROUTINE FOLLOW-UP AND X-RAYS. A YEAR AFTER HIS ORIGINAL SURGERY AND FORMER SURGEON FOUND ALL FLUID IN HIS HIP AND THEN HAD A HEAD, NECK, AND LINER SWAPOUT. BONE SCAN LIT UP AROUND THE STEM AND CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 0DEG 34MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 37470502

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention