BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL INSTRUM

    MDR report key: 1449401 · Received August 21, 2009

    Report

    Report Number
    1822565-2009-00909
    Event Type
    Injury
    Date Received
    August 21, 2009
    Report Date
    July 22, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL INSTRUMENTATION FEMORAL SAW GUIDE SIZE 1, CATALOG #00541304114, LOT # UNK. GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL INSTRUMENTATION FEMORAL SAW GUIDE SIZE 2, CATALOG #00541304115, LOT # UNK. GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL INSTRUMENTATION FEMORAL SAW GUIDE SIZE 3, CATALOG #00541304116, LOT # UNK. GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL INSTRUMENTATION FEMORAL SAW GUIDE SIZE 4, CATALOG #00541304117, LOT # UNK. GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL INSTRUMENTATION FEMORAL SAW GUIDE SIZE 5, CATALOG #00541304118, LOT # UNK. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SAW BLADES ARE BECOMING VERY HOT DURING USE, CAUSING METALLIC ABRASIONS AND THERMAL DAMAGE OF THE BONE. THIS IS OCCURRING IN NUMEROUS SURGERIES, THEREFORE, THIS REPORT IS NOT EVENT SPECIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL INSTRUM KNEE INSTRUMENT LXH ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CATALOG #00541304115| INSTRUMENTATION FEMORAL SAW GUIDE SIZE 3 LOT# UNK,| FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL| MULTI-REFERENCE 4-IN-1 FEMORAL INSTRUMENTATION| FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL| CATALOG #00541304118| CATALOG #00541304116| INSTRUMENTATION FEMORAL SAW GUIDE SIZE 4| INSTRUMENTATION| FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL| CATALOG #00541304114| FEMORAL SAW GUIDE SIZE 1| GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM| FLEX SYSTEM MULTI-REFERENCE 4-IN-1 FEMORAL| INSTRUMENTATION FEMORAL SAW GUIDE SIZE 5 LOT# UNK| CATALOG #00541304117