BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS PROXIMAL TIBIAL SPINDLE

    MDR report key: 362188 · Received November 21, 2001

    Report

    Report Number
    1825034-2001-00114
    Event Type
    Injury
    Date Received
    November 21, 2001
    Date of Event
    August 22, 2001
    Report Date
    November 21, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    KRO
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS ¿ MEDICAL PRODUCT: COMPRESS 4 BOLT CONCENTRC CLMP CATALOG #: CP110351, LOT #: 113830. COMPRESS CLAMP TIBIAL, CATALOG #: CP110501, LOT #: 111070. LIGAMENT ANCHOR WASHER WITH SCREW, CATALOG #: CP160110, LOT #: 114410. TIBIAL ANCHOR SCREW, CATALOG #: CP160232, LOT #: 114440. BELLEVILLE WASHER SET, CATALOG #: PM550754, LOT #: 114390. COMPRESS ANCHOR PLUG, CATALOG #: RD125010, LOT #: 612530. COMPRESS NUT, CATALOG #: RD125050, LOT #: 706360. TRANSVERSE PIN, CATALOG #: RD125061, LOT #: 889000. FINN TIBIAL BUSHING, CATALOG #: 153851, LOT #: 361540. FINN FEMORAL BUSHING, CATALOG #: 153852, LOT #: 939970. FINN LOCKING PIN, CATALOG #: 153861, LOT #: 916170. FINN REINFORCED YOKE, CATALOG #: 153865, LOT #: 631720. FINN AXLE, CATALOG #: 153872, LOT #: 940070. FINN MODULAR TIBIAL BEARING, CATALOG #: 153982, LOT #: 852610. FINN MODULAR RESURFACING FEMORAL, CATALOG #: 153802, LOT #: 634170. FINN MODULAR TIBIAL STEM, CATALOG #: 153816, LOT #: 687360.

    Description of Event or Problem · 1

    LEFT TIBIA TUMOR RESECTION, UTILIZING FINN ROTATING HINGE KNEE WITH COMPRESS FIXATION, WAS PERFORMED IN 1999. REVISION WAS PERFORMED IN 2001, DUE TO FRACTURE OF PROXIMAL TIBIAL COMPONENT. ALL HARDWARE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52686 COMPRESS PROXIMAL TIBIAL SPINDLE PROSTHESIS, CUSTOM, COMP. KRO BIOMET, INC. NOT APPLICABLE 113870

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R SEE H10 NARRATIVE