BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLER/GALANTE II POROUS TOTAL KNEE SYSTEM FEMORAL COMPONENT

    MDR report key: 1401522 · Received June 12, 2009

    Report

    Report Number
    1822565-2009-00663
    Event Type
    Injury
    Date Received
    June 12, 2009
    Date of Event
    February 19, 2008
    Report Date
    May 14, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICES WERE IN VIVO FOR OVER 15 YEARS. NO PRODUCT WAS RETURNED FOR EVALUATION. ALSO, NO X-RAYS WERE RETURNED FOR REVIEW. THE PROVIDED OPERATIVE NOTES FROM THE REVISION STATES: THE PATIENT WAS IMMEDIATELY SEEN TO HAVE A COMPLETELY BLACK KNEE INSIDE CONSISTENT WITH AN OLD BRAND OF CARBON-REINFORCED POLYETHYLENE; NOT CARBON-REINFORCED POLYETHYLENE." THE OPERATIVE REPORT GOES IN TO FURTHER DISCUSS "CARBON IN THE BONE" AND THE NEED TO REMOVE THIS CARBON POLYETHYLENE. HOWEVER, THE MG II ARTICULAR SURFACE WAS MANUFACTURED FROM CONVENTIONAL ULTRA-HIGH MOLECULAR-WEIGHT POLYETHYLENE. THIS BLACK DISCOLORATION DESCRIBED IN THE OPERATIVE REPORT IS CONSISTENT WITH METALLOSIS, THE PRESENCE OF METAL PARTICLES IN TISSUE WHICH ARE CREATED BY ABRASION OF THE METAL IMPLANTS. WITHOUT THE EXPLANTED DEVICES AND/OR ADDITIONAL INFORMATION, THE CAUSE OF THE WEAR, LOOSENING, OSTEOLYSIS, AND PAIN RESULTING IN THE NEED FOR REVISION SURGERY CAN NOT BE DEFINITIVELY DETERMINED. EVAL - 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 AVAILABLE INFORMATION, 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 BY THE PATIENT'S ATTORNEY THAT THE DEVICES WERE IMPLANTED IN 1992, AND THAT THE PATIENT WAS REVISED IN 2008, DUE TO PAIN AND SWELLING. UPON REVISION OF THE KNEE, LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AND WEAR OF THE POLYETHYLENE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLER/GALANTE II POROUS TOTAL KNEE SYSTEM FEMORAL COMPONENT KNEE PROSTHESIS HSA ZIMMER, INC. NA 69414600

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R MILLER/GALANTE II PRECOAT TOTAL KNEE SYSTEM TIBIAL| ARTICULAR SURFACE CATALOG#00511005009 LOT#79642500| MILLER/GALANTE II TOTAL KNEE SYSTEM TIBIAL| PLATE