BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ALL POLY PATELLA

    MDR report key: 2172624 · Received July 20, 2011

    Report

    Report Number
    1822565-2011-01664
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ZIMMER
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: X-RAYS WERE NOT PROVIDED. SURGICAL NOTES WERE PROVIDED AND SURGICAL TECHNIQUE REPORTED WAS REVIEWED TO BE CORRECT. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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 PATIENT UNDERWENT A REVISION SURGERY FOR A CRACKED AND LOOSE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ALL POLY PATELLA HTG ZIMMER 61321769

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention