BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH

    MDR report key: 15459302 · Received September 20, 2022

    Report

    Report Number
    0001822565-2022-02729
    Event Type
    Injury
    Date Received
    September 20, 2022
    Report Date
    November 22, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KTT
    UDI-DI
    00889024039513
    PMA / PMN Number
    K151907
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EVENT OCCURRED BETWEEN (B)(6) 2021 AND (B)(6) 2022. CONCOMITANT MEDICAL PRODUCTS: CMN FEMORAL NAIL, CCD 130°, LEFT, ø 10 MM, 34 CM, CATALOG#: 47249334310, LOT#: 3020635. CMN LAG SCREW, ø 10.5 MM, 120 MM INCLUDING SET SCREW, CATALOG#: 47248512010, LOT#: 3042375. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD, CATALOG#: 47248403550, LOT#: 65007883. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD, CATALOG#: 47248403750, LOT#: 64997560. CEPHALOMEDULLARY NAIL CAP 5 MM HEIGHT, CATALOG#: 47248700205, LOT#: 64745428. REPORT SOURCE FOREIGN: GERMANY. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT CURRENTLY REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. RADIOGRAPHS WERE PROVIDED. IMAGES ASSESSED BUT NOT SENT TO MMI FOR REVIEW DUE TO POOR PHOTOCOPY IMAGING QUALITY. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO REPAIR A LEFT, COMMINUTED, SUBTROCHANTERIC FRACTURE. ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE CONNECTION BETWEEN THE TITANIUM ROD OF THE FEMUR AND THE SCREW SPINDLE OF THE JOINT HEAD LOOSENED AND SHIFTED. THE FRACTURE HAS BEEN UNABLE TO HEAL DUE TO THE LOOSENING AND CONSTANT MOVEMENTS. AN ADDITIONAL SURGERY IS PENDING. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126973 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION KTT ZIMMER BIOMET, INC. 2232-04-18 65046164 00889024039513

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10 NARRATIVE.