BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 2031127 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00708
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE METAL INSERT WAS RETURNED DISENGAGED FROM THE ARTICULAR SURFACE. THE LOCKING SCREW WAS FUNCTIONALLY TESTED USING THE APPROPRIATE THREAD GAUGES AND FOUND TO BE CONFORMING. THE METAL INSERT CONFORMS TO PRINT SPECS. BOTH THE INFERIOR AND SUPERIOR SURFACES OF THE ARTICULAR SURFACE EXHIBIT MINOR WEAR AND SCRATCHES. THE INFERIOR SURFACE HAS SCRATCHES IN A CIRCULAR PATTERN, INDICATIVE OF MOTION BETWEEN THE POLY AND THE BASEPLATE, CAUSED BY TRAPPED THIRD BODY PARTICLES BETWEEN THE TWO IMPLANTS. THE LOCKING TABS ON THE POSTERIOR SURFACE OF THE POLY EXHIBIT DEFORMATION. THE INSERTION POINT FOR THE METAL TAB DOES NOT SHOW SIGNS OF DAMAGE. THE LOCKING SCREW HAS MINOR MARKS AND SCRATCHES ON THE SHAFT AND NO DEFORMITIES ON THE HEAD OR THREADS. THE METAL INSERT SHOWS ONLY VERY MINOR SCRATCHES OR SIGNS OF WEAR. THE X-RAYS TAKEN SHOWED DISLOCATION OF THE SUPPORT SCREW FROM THE POLY. SURGICAL NOTES WERE NOT INCLUDED. WITHOUT ADD'L INFO, THE EXACT CAUSE OF THE METAL INSERT DISLOCATING FROM THE ARTICULAR SURFACE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPEC. DIMENSIONAL AND FUNCTIONAL ANALYSIS WAS ALSO PERFORMED. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED AT THE ER WITH A LOCKED KNEE. A REVISION WAS PERFORMED DUE TO DISLOCATION OF THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER, INC. 78048800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention