BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 3060046 · Received April 11, 2013

    Report

    Report Number
    1822565-2013-00632
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 8, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO DEVICE, PHOTOS, PT FACTOR INFO, 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 INFO 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REPORTED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S KNEE WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154182 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER, INC. 61412148

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEXGEN LPS-FLEX ARTICULAR SURFACE:| CATALOG #00596405012, LOT #61294739