BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 3417765 · Received October 9, 2013

    Report

    Report Number
    3007963827-2013-00035
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    August 8, 2013
    Report Date
    September 9, 2013
    Manufacturer
    ZIMMER
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: THE PRIMARY OPERATIVE NOTES STATE THAT THE COMPUTER ASSISTED GUIDE WAS USED FOR MAPPING. NOTES ALSO STATE THAT ALIGNMENT, STABILITY AND MOTION WERE ACHIEVED WITH THE TRIAL COMPONENTS, AND SOFT TISSUE RELEASE WAS PERFORMED FOR CORRECTION. PATIENT UNDERWENT MANIPULATION PROCEDURE WITH NO ANOMALIES NOTED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION CODES: 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 IS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY REGAINING RANGE OF MOTION REQUIRING MANIPULATION POST TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513078 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER 62357859

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention NEXGEN LPS-FLEX ARTICULAR SURFACE,| NEXGEN PATELLA COMPONENT,| CATALOG #00591605001, LOT #62281196| CATALOG #00597206535, LOT #62378349,| MANUFACTURED IN (B)(4)| CATALOG #00591706010, LOT #62114983| NEXGEN FLUTED STEMMED TIBIAL,