BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 3213584 · Received July 3, 2013

    Report

    Report Number
    1822565-2013-01059
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    March 14, 2012
    Report Date
    June 4, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE IMPLANTED COMPONENTS WERE CONFIRMED AS COMPATIBLE. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF X-RAYS AND/OR PRODUCT OR FURTHER INFO. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATION 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 AVAILABLE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304421 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER, INC. 60718673

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention