BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2230790 · Received August 23, 2011

    Report

    Report Number
    1822565-2011-01916
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 26, 2011
    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 REQUESTED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THERE THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION - 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 REVISED FOR DISLOCATION AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61524836

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention