BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 3760814 · Received April 9, 2014

    Report

    Report Number
    1822565-2014-00472
    Event Type
    Injury
    Date Received
    April 9, 2014
    Report Date
    March 11, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER X-RAYS NOR OPERATIVE NOTES HAVE BEEN PROVIDED FOR REVIEW. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO ARE UNKNOWN. WITH THE INFORMATION PROVIDED, A ROOT CAUSE CANNOT BE DETERMINED. PRODUCT COMPATIBILITY HAS BEEN REVIEWED WITH NO ISSUES NOTED. 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 ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, 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 PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213949 CONTINUUM TM SHELL WITH CLUSTER HOLES LZO ZIMMER, INC. 61859908

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE FOLLOWING ITEM WAS MANUFACTURED BY (B)(4)| CATALOG #00875200932, LOT #61864856| CONTINUUM LONGEVITY LINER:| VERSYS FEMORAL HEAD:| TRABECULAR METAL FEMORAL STEM:| CATALOG #00801803201, LOT #61123366| (B)(4)| CATALOG #00786401300, LOT #61967812