BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA

    MDR report key: 3877987 · Received June 6, 2014

    Report

    Report Number
    1822565-2014-00704
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 15, 2009
    Report Date
    May 8, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVISION OPERATIVE NOTES CONFIRM NO EVIDENCE OF INFECTION OR SYNOVITIS WAS IDENTIFIED. OSTEOPHYTES WERE VISUALIZED AROUND THE MEDIAL AND LATERAL BOARDERS ALONG WITH THE NOTCH AND A SMALL OSTEOPHYTE OVERHANGING LATERALLY. THIS OSTEOPHYTE WAS REMOVED AS THE PT WAS EXPERIENCING PAIN IN THIS REGION. OVERALL TRACKING AND STABILITY WERE REPORTED TO BE STABLE. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. 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 PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331073 GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA KRR ZIMMER, INC. 60756227

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention