BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2041111 · Received March 29, 2011

    Report

    Report Number
    1822565-2011-00767
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NEITHER X-RAYS NOR OP-NOTES WERE PROVIDED. AS SUCH, SURGICAL TECHNIQUE AND RESULTS CANNOT BE REVIEWED. BASED ON THE AVAILABLE INFO, AN SPECIFIC CAUSE FOR THE REPORTED CONDITION CANNOT BE DETERMINED. THERE ARE NO INDICATIONS OF PRODUCT CONTRIBUTION. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 60716578

    Patients

    Seq Age Sex Outcome Treatment
    1 Other