BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2963426 · Received February 13, 2013

    Report

    Report Number
    1822565-2013-00307
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    September 19, 2011
    Report Date
    January 14, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO X-RAYS OR PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) WERE PROVIDED. REVIEW OF SURGICAL REPORTS PROVIDED INDICATES THE SURGICAL TECHNIQUE WAS FOLLOWED. SURGICAL REPORT DATED (B)(6) 2011 STATES THAT A SYNOVECTOMY AND LATERAL RELEASE WERE PERFORMED ON THAT DAY DUE TO PERSISTENT PAIN AND PATELLOFEMORAL IMPINGEMENT. THE PATELLOFEMORAL IMPINGEMENT MAY HAVE BEEN DUE TO THE REPORTED TIGHT PLICAL BANDS, AS INDICATED IN THAT REPORT. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A SYNOVECTOMY AND LATERAL RELEASE DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63096 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER, INC. 60642053

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention THE FOLLOWING WERE MANUFACTURED BY ZIMMER B.V.| (B)(4): NEXGEN ALL POLY PATELLA| CATALOG # 00596204014, LOT # 60655793| NEXGEN LPS-FLEX ARTICULAR SURFACE| CATALOG # 00597206532, LOT # 60660914| CATALOG # 00598604702, LOT # 60660914| NEXGEN STEMMED TIBIAL COMPONENT