BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 3201669 · Received June 28, 2013

    Report

    Report Number
    1822565-2013-01032
    Event Type
    Injury
    Date Received
    June 28, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRIMARY SURGICAL NOTES STATED THAT THE THA WAS FOR RIGHT HIP ARTHRITIS PAIN DYSFUNCTION. THE FINAL THA WAS TAKEN THROUGH RANGE OF MOTION AND HAD GOOD RANGE OF MOTION, GOOD STABILITY AND GOOD LEG LENGTH REPRODUCTION, GOOD STABILITY AND GOOD LEG LENGTH REPRODUCTION. NO COMPLICATIONS NOTED. F/U OFFICE NOTES STATE THAT THE TOTAL HIP COMPONENTS APPEAR TO BE IN EXCELLENT POSITION. THE PROVIDED X-RAYS WERE UNREMARKABLE. CAUSE CANNOT BE DEFINITELY DETERMINED. EVAL CODES: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING LATERAL HIP DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296678 CONTINUUM TM SHELL WITH CLUSTER HOLES LZO ZIMMER INC 61922706

    Patients

    Seq Age Sex Outcome Treatment
    1 Other WINTERTHUR, SWITZERLAND| LOT #2632524 MANUFACTURED BY ZIMMER GMBH,| ZIMMER M/L TAPER FEMORAL STEM,| BIOLOX FEMORAL HEAD, CATALOG #00877504001,| CATALOG #00771101040, LOT #61729290