BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL W/CLUSTER HOLES POROUS

    MDR report key: 2230758 · Received August 23, 2011

    Report

    Report Number
    1822565-2011-01949
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ALLEGED ISSUE OF DAMAGED THREAD IN THE CONTINUUM SHELL WAS FOUND TO BE CORRECT. IT APPEARS THAT THE THREADS HAD BEEN CROSS THREADED WHEN ATTACHING THE IMPACTOR. THIS IS FOUND FROM THE LEADING THREAD DAMAGE AND THE DIFFERENT IMPACT SITES AROUND THE TREADS, SHOWING THAT THE THREADS HAD NOT GAINED ANY ENGAGEMENT WITH THE IMPACTOR PRIOR TO USE. EVALUATION: THE DEVICE HISTORY RECORD WAS REVIEWED AND THE DEVICE WAS FOUND TO BE CONFORMING AT THE TIME OF MANUFACTURING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AS THE SURGEON TRIED TO IMPLANT THE CUP, IT WOULD NOT STAY ATTACHED TO THE CUP INSERTER. SURGEON FELT IT WAS THE CUP THREADS THAT WERE THE PROBLEM. ANOTHER CUP OF THE SAME SIZE WAS OPENED AND USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM TM SHELL W/CLUSTER HOLES POROUS LPH ZIMMER, INC. 61742002

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR