BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2120089 · Received June 7, 2011

    Report

    Report Number
    1822565-2011-01337
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: OPERATIVE NOTES FROM BOTH THE PRIMARY AND REVISION SURGERIES WERE PROVIDED AND REVIEWED. THE SURGEON INDICATES IN THE REVISION NOTES HE BELIEVES THE ISSUE TO BE INTRINSIC TO THE PT'S SOFT TISSUES. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THE REPORTED STIFFNESS CANNOT BE DETERMINED. THERE ARE NO INDICATIONS, HOWEVER, OF PRODUCT CONTRIBUTION. 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 REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT MANIPULATION AND SOFT TISSUE RELEASE OF THE KNEE DUE TO STIFFNESS. THE ARTICULAR SURFACE WAS THEN REVISED DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61613932

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention