BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH UNI-HOLE

    MDR report key: 3975725 · Received July 9, 2014

    Report

    Report Number
    1822565-2014-00831
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED AGAINST THE MANUFACTURING LOTS OF THE PRODUCT INVOLVED IN THIS COMPLAINT. PRIMARY OPERATIVE NOTES WERE PROVIDED WHICH WERE UNREMARKABLE. SIX-WEEK POST OP, X-RAYS WERE RETURNED FOR REVIEW WHICH SHOW WELL PLACED COMPONENTS, HOWEVER IN COMPARISON TO THE NON-OPERATIVE JOINT THE NECK LENGTH APPEARS LONGER IN THE OPERATIVE SIDE. PRE-OPERATIVE X-RAYS HAVE NOT BEEN PROVIDED. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY, AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERED THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT EXPERIENCED STIFFNESS IN THE RIGHT HIP AND IT RESOLVED ITSELF WITHOUT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400759 CONTINUUM TM SHELL WITH UNI-HOLE LZO ZIMMER, INC. 08/31/2023

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other ZIMMER M/L TAPER FEMORAL STEM: CAT #00771101220,| LOT #62615782| VITAMIN E NEUTRAL LINER: CAT #00885101236,| LOT #62553895