BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA

    MDR report key: 930049 · Received October 19, 2007

    Report

    Report Number
    1822565-2007-00346
    Event Type
    Injury
    Date Received
    October 19, 2007
    Date of Event
    September 20, 2007
    Report Date
    September 26, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE EXHIBITS FRACTURE DAMAGE AT THE BASE OF THE SPINE WITH DEEP GOUGE MARKS ON ANTERIOR OR POSTERIOR SIDE. THE BACKSIDE SURFACE SHOWS ROTATIONAL STRIATIONS/MARKS AND THE ARTICULATING SURFACES EXHIBIT WEAR DAMAGE FROM ITS ORIGINAL STATE. THE CAUSE COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFO. H6: EVAL CODES: SCANNING ELECTRON MICROSCOPY ANALYSIS WAS CONDUCTED ON THE SPINE FRACTURE SURFACE AND ARTICULATING SURFACE OF THE INSERT. SPINE FRACTURE SURFACE SHOWED BEACH MARKS AND STRIATED FEATURES INDICATING FRACTURE OCCURRED BY FATIGUE. THIRD BODY WEAR PARTICLES OBSERVED INDICATED C, O, SI, CI, AND TI ELEMENTAL PEAKS IN THE ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS. EDS ANALYSIS OF THE ARTICULATING SURFACE MATERIAL SHOWED A CARBON (C) PEAK IN THE SPECTRUM, TYPICAL OF UHMWPE X-RAYS ARE NOT AVAILABLE FOR REVIEW. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2004. POST-OP, THE PT COMPLAINED OF INSTABILITY OF KNEE. THE SURGEON DID AN X-RAY AND DETERMINED THE IMPLANT LOOKED FIXED. WHEN HE OPENED THE KNEE IN 2007, HE FOUND THE POST WAS SHEARED OFF OF THE 14MM ARTICULATING SURFACE. THE SURGEON STATED THAT THE FIBULA AND TIBIA HAD REMAINED IN ALIGNMENT. THE SURGEON PERFORMED A POLY EXCHANGE USING A 17 MM ARTICULATING SURFACE. THE SURGEON MADE THE DECISION TO IMPLANT THE 17MM ARTICULATING SURFACE WITHOUT A LOCKING SCREW INSTEAD OF REVISING THE TIBIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA KNEE PROSTHESIS HSH ZIMMER, INC. NA 60127161

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R