BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE ALL POLY PATELLA

    MDR report key: 2033457 · Received March 24, 2011

    Report

    Report Number
    1822565-2011-00722
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    April 15, 2010
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRE-OP AND POST OP X-RAYS ARE NOT RETURNED TO STUDY THE FIXATION. SURGICAL NOTES ARE NOT AVAILABLE TO STUDY THE SURGICAL PROCEDURE FOLLOWED. HOWEVER, THE SURGEON MENTIONS CEMENT COMING LOOSE DURING PT'S FOLLOW UP VISIT, BUT THERE IS NO CONCLUSIVE EVIDENCE TO CONFIRM THE SAME. DEPUY BONE CEMENT WAS USED FOR THE IMPLANTATION WHICH MAY NOT HAVE BEEN COMPATIBLE WITH ZIMMER IMPLANTS. THIS COULD HAVE LED TO EARLY LOOSENING, BUT CANNOT BE CONFIRMED WITH THE AVAILABLE INFO. 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS SEVERE PAIN DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE ALL POLY PATELLA JWH ZIMMER 60769613

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other MANUFACTURED IN (B)(4)| CATALOG # 00598003702, LOT # 60777857| CATALOG # 00596403010, LOT # 60798902,| LOT # 60728598, (B)(4)| NEXGEN STEMMED TIBIAL COMPONENT,| NEXGEN LPS-FLEX ARTICULAR SURFACE,| NEXGEN FEMORAL COMPONENT, CATALOG # 00576401452,