BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI-KNEE HIGH-FLEX FEMORAL COMPONENT

    MDR report key: 2822445 · Received November 2, 2012

    Report

    Report Number
    1822565-2012-02261
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 18, 2011
    Report Date
    October 3, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVIEW OF PRIMARY SURGICAL REPORTS PROVIDED INDICATES SURGICAL TECHNIQUE WAS FOLLOWED. REVISION SURGERY NOTE REPORTS THAT RADIOGRAPHS SHOWED A CONTINUOUS RADIOLUCENT LINE BETWEEN THE FEMORAL COMPONENT AND UNDERLYING BONE AND A BONE SCAN SHOWED SIGNIFICANTLY INCREASED UPTAKE IN THE MEDICAL COMPARTMENT. NO POST-OP X-RAYS WERE RECEIVED, SO NO CHECK COULD BE MADE FOR CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: 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 PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-KNEE HIGH-FLEX FEMORAL COMPONENT HSX ZIMMER, INC. 61272158

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention