BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2082944 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01090
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EXPLANTS ARE NOT AVAILABLE FOR REVIEW AS THEY REMAIN IN-VIVO. FURTHERMORE, IMPLANT COMPATIBILITY WAS CONFIRMED VIA THE NEXGEN KNEE PROFILER. X-RAYS WERE NOT PROVIDED. AS SUCH, THE IMPLANT CONSTRUCT CANNOT BE ANALYZED RADIOGRAPHICALLY. OPERATIVE NOTES FROM THE PRIMARY SURGERY WERE PROVIDED AND REVIEWED. NOTHING EXCEPTIONAL WAS NOTED. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THE REPORTED CONDITION 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING RIGHT KNEE PAIN WHICH ALSO MAKES NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER 61609342

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG #00598603701, LOT #61636453| BOTH MFG AT ZIMMER (B)(4)| LOT #61626984| NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE| CATALOG #00596203010, LOT #61637329| MFG AT ZIMMER, (B)(4)| NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT| NEXGEN ALL POLY PATELLA: CATALOG #00597206529,