BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 4112854 · Received September 17, 2014

    Report

    Report Number
    1822565-2014-01141
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: PRIMARY OPERATIVE NOTES WERE REVIEWED AND WERE UNREMARKABLE. X-RAYS WERE REVIEWED AND SHOW IMPLANTS WITH APPROPRIATE FIT AND ORIENTATION WITH NO GROSS CHANGES BETWEEN THE IMMEDIATE POST-OP X-RAY AND 12 MONTH POST-OP X-RAY. IN GENERAL, PATIENT 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 IS UNKNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION 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 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 THE PATIENT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577141 CONTINUUM TM SHELL WITH CLUSTER HOLES LZO ZIMMER, INC. 61740002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ZIMMER M/L TAPER FEMORAL STEM: CAT #00771101200,| LOT #61721051| CONTINUUM TRILOGY ALLOFIT: CAT #: 00875101336,| LOT #: 61666135| BIOLOX FEMORAL HEAD: CAT #: 00877503601,| LOT#: 2618624