BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY LPS-FLEX ARTICULAR SURFACE

    MDR report key: 1924422 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01289
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IT IS REPORTED THAT SCRATCHES WERE OBSERVED ON BOTH MEDIAL AND LATERAL ARTICULATING SURFACES POSSIBLY DUE TO BONE CEMENT DEBRIS BUT CANNOT BE CONFIRMED. FURTHER INVESTIGATION CAN BE MADE WITH THE RETURN OF PRODUCT. WITH THE EXISTING INFO, A DEFINITIVE CAUSE FOR PATIENT'S PAIN AND REVISION CANNOT BE DETERMINED. EVAL CODES: MFG RECORDS WERE CHECKED OR THE COMPONENT AND THEY ARE CONFORMING TO SPECIFICATIONS INDICATING THERE WERE MANUFACTURED, INSPECTED AND PACKAGED TO SPECIFICATION. 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 ADD'L 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 PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY LPS-FLEX ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 61410861

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention