BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM TRABECULAR METAL SHELL

    MDR report key: 3113146 · Received May 9, 2013

    Report

    Report Number
    1822565-2013-00773
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRIMARY SURGICAL NOTES STATE THAT THE HIP WAS FOUND TO HAVE STABLE RANGE OF MOTION, LEG LENGTHS AND OFFSET SEEMED TO BE EQUALIZED. THERE HAD BEEN NO COMPLICATIONS NOTED. F/U NOTES STATE THAT THE PT HAS BEEN DOING WELL EXCEPT FOR SOME OCCASIONAL NOISES. X-RAYS HAVE BEEN PROVIDED AND FOUND TO HAVE WELL ALIGNED DEVICES. THERE WAS NO INDICATION OF LINER MALPOSITIONING OR LOOSENING. IN GENERAL, CERAMIC ON CERAMIC TOTAL HIP REPLACEMENTS HAVE A HISTORY OF MAKING NOISE WHILE IN MOTION. CAUSE CANNOT BE DEFINITELY DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING A CLICKING OF THEIR HIP WITH EXTENSION AND EXTERNAL ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204846 CONTINUUM TRABECULAR METAL SHELL LZO ZIMMER INC 61985841

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT #60842454| ZIMMER M/L FEMORAL STEM, CATALOG #00771100640,| SELF-TAPPING BONE SCREW, CATALOG #00625006535,| (B)(4)| LOT #2627494, MANUFACTURED BY ZIMMER| BIOLOX DELTA HEAD, CATALOG #00877503201,| LOT #61980066, MANUFACTURED BY ZIMMER| (B)(4)