BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 1910997 · Received November 23, 2010

    Report

    Report Number
    1822565-2010-01195
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO SURGICAL X-RAYS PROVIDED TO UNDERSTAND THE FIXATION. SURGICAL NOTES PROVIDED DO NOT REVEAL ANY ABNORMALITIES WITH THE SURGICAL TECHNIQUE FOLLOWED. PRE-OP AND POST-OP X-RAYS MIGHT HELP IN FURTHER INVESTIGATION OF THE COMPLAINT. PATIENT'S BUILD, ACTIVITY LEVEL AND MULTIPLE PROCEDURES DONE IN THE PAST 10 YEARS (PER PATIENT'S HISTORY) COULD BE CONTRIBUTING TO INSTABILITY. HOWEVER, WITH THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR PATIENT'S INSTABILITY 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 INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT KNEE PROSTHESIS HSA ZIMMER, INC. 61447942

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention CATALOG #00597206535, LOT #61437328| NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA