BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 4142806 · Received September 23, 2014

    Report

    Report Number
    2648920-2014-00245
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT HEARS A CLICK FROM HIS HIP IMPLANT DURING SEXUAL ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590991 CONTINUUM TM SHELL WITH CLUSTER HOLES LZO ZIMMER MANUFACTURING B.V. 62051755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BIOLOX DELTA HEAD, CATALOG #00877504002,| (B)(4),| LOT #2637813 MANUFACTURED BY ZIMMER (B)(4),| MANUFACTURED BY ZIMMER (B)(4),| ZIMMER M/L TAPER FEMORAL STEM,| CATALOG #00771101320, LOT #61791512,