BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2921443 · Received January 9, 2013

    Report

    Report Number
    1822565-2013-00040
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    February 17, 2011
    Report Date
    December 11, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY - NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. FIT AND ORIENTATION COULD NOT BE EVALUATED WITHOUT X-RAYS OR SURGICAL NOTES. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S KNEE WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13237 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER, INC. 60804118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG #00598003702, LOT #60777855,| CATALOG #00596403210, LOT #60835262| NEXGEN LPS-FLEX ARTICULAR SURFACE| MANUFACTURED AT ZIMMER (B)(4)| NEXGEN STEMMED TIBIAL COMPONENT,