BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 5249828 · Received November 25, 2015

    Report

    Report Number
    1822565-2015-02467
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    September 17, 2015
    Report Date
    October 28, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #00771101020, M/L TAPER STEM, LOT #62130196. CATALOG #00875101436, CONTINUUM, TRILOGY IT, ALLOFIT IT LINER, LOT #62157691 - MANUFACTURED BY ZIMMER B.V., (B)(4). CATALOG #00877503602, BIOLOX DELTA HEAD, LOT #2686825- MANUFACTURED BY ZIMMER (B)(4). IT WAS NOTED FROM THE OPERATIVE NOTES THAT THE TRIAL COMPONENTS GAVE EXCELLENT FIT AND RADIOGRAPHS TAKEN INTRAOPERATIVE ENSURE THE PROPER SIZING AND POSITION. TRIAL COMPONENTS WERE REMOVED AND FINAL COMPONENTS WERE IMPLANTED. LEG LENGTHS WERE MEASURED TO BE EQUALIZED. OFFICE VISIT NOTES STATE THAT THE X-RAYS REVEALED FEW DEGREES VARUS ON STEM AND SOME LUCENT LINES. NO CHANGE IN POSITION OR FRACTURE IS NOTED. IT WAS ALSO NOTED THAT THE PATIENT'S SYMPTOMS ARE CONCERNING FOR EARLY LOOSENING. REVIEW OF THE COMPATIBILITY OF THE DEVICES CONFIRMED THAT THESE ARE AN APPROVED COMPATIBLE COMBINATION. PRODUCT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATIONS. A DEFINITE ROOT CAUSE FOR THE PATIENT'S PAIN CANNOT BE CONFIRMED WITH THE INFORMED PROVIDED. THESE DEVICES ARE USED FOR TREATMENT.

    Description of Event or Problem · 1

    IT IS REPORTED A PATIENT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780140 CONTINUUM TM SHELL WITH CLUSTER HOLES LZO LZO ZIMMER INC 62297507

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other