BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR FLEX FEMORAL COMPONENT

    MDR report key: 3010287 · Received March 14, 2013

    Report

    Report Number
    1822565-2013-00481
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    September 24, 2009
    Report Date
    February 15, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVICES, PHOTOS, PT FACTOR INFORMATION, SURGICAL NOTES OR X-RAYS WERE RECEIVED. PAIN CAN BE INFLUENCED BY MANY FACTORS. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO, PT WEIGHT, PT ACTIVITY, BONE QUALITY, IMPLANT SIZE, SURGICAL TECHNIQUE, AND REHABILITATION PROGRAM. 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'S KNEE WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108231 NEXGEN CR FLEX FEMORAL COMPONENT MBH ZIMMER, INC. 60875891

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention