BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM, TRILOGY IT, ALLOFIT IT, LINER

    MDR report key: 3111187 · Received May 8, 2013

    Report

    Report Number
    1822565-2013-00759
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FROM 3500A. EVALUATION SUMMARY: UPON EXPOSURE, THE LINER'S CONSTRAINING TABS WERE ORIENTED AT APPROXIMATELY 2 AND 8 O'CLOCK ON A RIGHT HIP. SURGICAL TECHNIQUE INSTRUCTS THAT IN ORDER TO OPTIMIZE RANGE OF MOTION, THE SUPERIOR FINGER OF THE CONSTRAINED LINER SHOULD BE PLACED AT 11 O'CLOCK ON A RIGHT HIP. AT THE REVISION, THE REVISING SURGEON CORRECTED THIS SURGICAL TECHNIQUE DEVIATION BY PLACING THE NEW CONSTRAINED LINER WITH THE TABS AT 11 AND 5 O'CLOCK. NO DEVICES WERE RETURNED, SO THE ACTUAL CONDITION OF THE COMPONENTS IS UNKNOWN. ADDITIONAL 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. DEVIATION FROM THE SURGICAL TECHNIQUE LIKELY LED TO THE PT'S DISLOCATION DUE TO THE NON-OPTIMAL RANGE OF MOTION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202227 CONTINUUM, TRILOGY IT, ALLOFIT IT, LINER KWZ ZIMMER, INC. 62142585

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Required Intervention