BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE

    MDR report key: 2033456 · Received March 24, 2011

    Report

    Report Number
    1822565-2011-00720
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    September 18, 2009
    Manufacturer
    ZIMMER, INC.
    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 NOT RETURNED TO STUDY THE FIXATION. SURGICAL NOTES NOT AVAILABLE TO STUDY THE SURGICAL PROCEDURE FOLLOWED. TOO MUCH KNEE MOVEMENT COULD BE DUE TO WEAR OF THE ARTICULATE SURFACE BUT CANNOT BE CONFIRMED. THE CLICKING COULD BE DUE TO PATELLA TRACKING ISSUES WHICH ALSO CANNOT BE CONFIRMED. THE PT'S HISTORY AND DEMOGRAPHICS ARE UNAVAILABLE FOR ANALYSIS, THE PROBABLE CAUSE FOR PT'S PAIN AND THE CLICKING EXPERIENCED CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND AND 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 PAIN AND CLICKING SOUND WITH TOO MUCH MOVEMENT. DEVICE WAS IMPLANTED IN (B)(6) 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE JWH ZIMMER, INC. 63593100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MANUFACTURED AT ZIMMER (B)(4)| CATALOG # 00597201601, LOT # 07223900| NEXGEN CRUCIATE PEGGED TIBIAL COMPONENT,| NEXGEN KNEE ALL POLY PATELLA,| BONE SCREW, CATALOG # 00511007025, LOT # 17673600| BONE SCREW, CATALOG # 00511007060, LOT # 63593100,| CATALOG # 00597206538, LOT # 63781800| NEXGEN CRUCIATE RETAINING FEMORAL COMPONENT,| CATALOG # 00597204501, LOT # 62930800