BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX PRECOAT FEMORAL COMPONENT

    MDR report key: 3841153 · Received May 13, 2014

    Report

    Report Number
    1822565-2014-00607
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    June 13, 2011
    Report Date
    April 22, 2014
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNKNOWN 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. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF RADIOGRAPHS AND/OR PRODUCT OR FURTHER INFORMATION. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285442 NEXGEN CR-FLEX PRECOAT FEMORAL COMPONENT JWH ZIMMER INC. 61315027

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention