BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2030642 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00651
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    July 30, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED COMPONENTS ARE COMPATIBLE PER THE NEXGEN KNEE PROFILER. NEITHER OPERATIVE NOTES NOR X-RAYS ARE AVAILABLE AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THE REPORTED CONDITION CANNOT BE DETERMINED. THERE ARE NO INDICATIONS, HOWEVER, OF ANY 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 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 PATIENT HAS A KNOCK/CLUNK SOUND IN KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT JWH ZIMMER, INC. 61237430

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG # 00591605001, LOT#61018390| NEXGEN FLUTED STEM MOBILE TIBIAL| NEXGEN PROLONG HIGHLY CROSSLINKED POLYETHLENE| LPS-MOBILE ARTICULAR SURFACE| PATELLA: CATALOG #00597206638, LOT#60975131| LOT# 68164202| CATALOG # 00591606102, LOT# 60987383| ZIMMER PALACOS CEMENT, CATALOG #1113140001