BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG CR ARTICULAR SURFACE

    MDR report key: 2051054 · Received April 5, 2011

    Report

    Report Number
    1822565-2011-00852
    Event Type
    Injury
    Date Received
    April 5, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNK WHETHER THE PT WAS REPLACED WITH FEMUR, TIBIAL BASEPLATE AND PATELLA AS WELL. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. PRODUCTS ARE NOT RETURNED FOR ANALYSIS. SURGICAL NOTES AND PRE/POST-OP X-RAYS ARE ALSO NOT AVAILABLE FOR STUDY. WITH THE AVAILABLE INFO, PROBABLE CAUSE FOR PAIN CANNOT BE DETERMINED. 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 REOPENED. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PROLONG CR ARTICULAR SURFACE JWH ZIMMER INC 60887625

    Patients

    Seq Age Sex Outcome Treatment
    1 Other