BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE FLEX PROLONG PATELLA

    MDR report key: 4826445 · Received June 8, 2015

    Report

    Report Number
    1822565-2015-00850
    Event Type
    Injury
    Date Received
    June 8, 2015
    Date of Event
    December 10, 2014
    Report Date
    May 5, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUT INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS NOTED THE PATIENT RECEIVED COMPETITOR KNEE COMPONENTS DURING A PREVIOUS REVISION. THE DEVICE(S) CAUSING OR CONTRIBUTING TO THIS REPORTED EVENT WERE NOT MANUFACTURED BY ZIMMER INC. ZIMMER, INC. CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. OTHER DEVICE USED: CATALOG #00111314001, PALACOS R+G BONE CEMENT, LOT #78714387, QTY 2, IMPLANTED (B)(6) 2014 - THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE FOUND. REVIEW OF PRIMARY OPERATIVE NOTES CONFIRMS PATIENT UNDERWENT A BILATERAL TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE RIGHT KNEE WAS ADDRESSED FIRST. TRIAL COMPONENTS REVEALED EXCELLENT STABILITY, GOOD TRACKING, AND FULL EXTENSION. THE PCL WAS SACRIFICED FOR SOFT TISSUE BALANCING. FINAL COMPONENTS WERE IMPLANTED AND REVEALED GOOD PATELLAR TRACKING. REVIEW OF PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. THE PATIENT UNDERWENT A FIRST RIGHT REVISION TOTAL KNEE ARTHROPLASTY DUE TO A FAILED TOTAL KNEE. AT THIS TIME, THE PATELLAR COMPONENT WAS NOT EXPLANTED, BUT THE REMAINING COMPONENTS IMPLANTED WERE A COMPETITOR'S PRODUCTS. REVIEW OF SECOND REVISION OPERATIVE NOTES REVEALS THAT THE PATIENT UNDERWENT A TWO-STAGE REVISION DUE TO SEPTIC RIGHT TOTAL KNEE, AT WHICH TIME ONLY THE PATELLAR COMPONENT AND BONE CEMENT WERE ZIMMER PRODUCTS. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT REC'D AN IMPLANT IN (B)(6) 2012. ON (B)(6) 2014 THE PT UNDERWENT AN IRRIGATION PROCEDURE DUE TO A STAPH INFECTION. THE PT CONTINUED TO REPORT PROBLEMS WITH INFECTION IN THE RIGHT KNEE AND ON (B)(6) 2014 HE UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION WHEN AN ANTIBIOTIC SPACER WAS PLACED. THE SECOND STAGE TOOK PLACE ON (B)(6) 2015.

    Description of Event or Problem · 1

    UPON REVIEW OF THE OPERATIVE NOTES, IT WAS DETERMINED THAT THE PATELLAR COMPONENT WAS REVISED DURING THE FIRST STAGE OF A TWO STAGE REVISION FOR A STAPH INFECTION. THE SECOND STAGE WAS COMPLETED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367928 NATURAL-KNEE FLEX PROLONG PATELLA JWH JWH ZIMMER, INC. 62166736

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention