BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    MDR report key: 3093663 · Received May 1, 2013

    Report

    Report Number
    1822565-2013-00724
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE X-RAY PROVIDED DOES NOT APPEAR TO REVEAL THAT THERE ARE ANY SIGNIFICANT ISSUES WITH THE DEVICES, WITH REGARD TO COMPONENT POSITION, ALIGNMENT, SIZING, OSTEOLYSIS, ETC. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS POSSIBLE TRAUMA, BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVIEWED UPON RETURN OF OPERATIVE REPORTS, PRODUCT OR FURTHER INFORMATION. EVALUATION: MANUFACTURING DOCUMENTATION WAS REVIEWED AND INDICATES THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. COMPLAINT RECORD REVIEW DOES NOT REVEAL ANY OTHER COMPLAINTS FOR THIS PRODUCT/LOT COMBINATION. THE DEVICE WAS NOT RETURNED; HOWEVER, THE PHOTOGRAPHS PROVIDED SHOW THE ARTICULAR SURFACE WITH DETACHED POST BESIDE IT. ALSO SHOWN IS WHAT APPEARS TO BE A FRAGMENT OF POLYETHYLENE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS EXPERIENCING KNEE DISCOMFORT AND INSTABILITY. THE PT WAS TAKEN TO THE OPERATING ROOM FOR A SCOPE WHICH DETERMINED THE POST ON THE POLY WAS FRACTURED. THE PT THEN UNDERWENT AN EXCHANGE OF THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189787 NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE JWH ZIMMER INC 61064647

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention