BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY LPS-FLEX ARTICULAR SURFACE

    MDR report key: 1911008 · Received November 23, 2010

    Report

    Report Number
    1822565-2010-01177
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO X-RAYS OR SURGICAL NOTES WERE PROVIDED TO STUDY THE FIXATION AND SURGICAL TECHNIQUE USED. PATIENT DEMOGRAPHICS ARE ALSO NOT AVAILABLE TO STUDY THE HISTORY AND ACTIVITY LEVEL. FLEX COMPONENTS ARE DESIGNED TO PROVIDE EXTENDED RANGE OF MOTION. WITH THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR PATIENT'S POOR RANGE OF MOTION AND SEVERE FLEXION CONTRACTION CANNOT BE DETERMINED. NO PRODUCT WAS RETURNED. 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 RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO POOR RANGE OF MOTION AND SEVERE FLEXION CONTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY LPS-FLEX ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 60183279

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention NEXGEN MIS STEMMED TIBIAL COMPONENT| NEXGEN LEGACY LPS-FLEX GSF FEMORAL COMPONENT| CATALOG #00576401352, LOT #61019607| CATALOG #00595002702, LOT #61022794