BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II SYSTEM ULTRA CONGRUENT TIBIAL INSERT

    MDR report key: 1373421 · Received May 1, 2009

    Report

    Report Number
    1822565-2009-00514
    Event Type
    Injury
    Date Received
    May 1, 2009
    Date of Event
    October 17, 2008
    Report Date
    April 1, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ON 10/17/08, THE NATURAL-KNEE II SYSTEM WAS REVISED DUE TO BREAKAGE OF THE ARTICULAR SURFACE AND WEAR ON THE FEMORAL AND TIBIAL BASEPLATE COMPONENTS. LOOSENING, OSTEOLYSIS AND PAIN WAS ALSO INDICATED AS REASONS FOR REVISION. THE DEVICES WERE IN VIVO FOR APPROXIMATELY 4 YEARS AND 9 MONTHS. THE DEVICES WERE NOT RETURNED FOR EVALUATION. HOWEVER, THE OPERATIVE NOTES FROM THE PRIMARY AND REVISION SURGERY WERE PROVIDED. THE REVISION SURGERY OPERATIVE NOTES INDICATES THAT FEMORAL CYSTS WERE PRESENT, AND THAT THE REVISION WAS NEEDED DUE TO "CATASTROPHIC FAILURE WITH PROBABLE DISPLACEMENT OF THE POLYETHYLENE AND METAL ON METAL WITH METALLOSIS." IT APPEARS FROM THE DESCRIPTION THAT THE BREAKAGE OF THE ARTICULAR SURFACE CAUSED CONTACT BETWEEN THE FEMORAL AND TIBIAL BASEPLATE COMPONENTS, THUS LEADING TO THEIR WEAR AND PERHAPS CONTRIBUTING TO THE METALLOSIS. HOWEVER, THE CAUSE OF THE ARTICULAR SURFACE BREAKAGE IS NOT ELABORATED UPON. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CAUSE CAN NOT BE DETERMINED. H6: EVALUATION: NO PRODUCT WAS RETURNED. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICES WERE IMPLANTED IN 2004, AND REVISED IN 2008, DUE TO THE ULTRA CONGRUENT TIBIAL INSERT BREAKING AND WEAR ON THE TIBIAL BASEPLATE AND FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II SYSTEM ULTRA CONGRUENT TIBIAL INSERT KNEE PROSTHESIS HSH ZIMMER, INC. NA 1199135

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R CATALOG # 630700200| NATURAL-KNEE II SYSTEM SINTERLOCK POROUS COATED| POSTERIOR STABILIZED FEMORAL COMPONENT| CATALOG # 621200010| NATURAL-KNEE II SYSTEM STEMMED TIBIAL BASEPLATE