BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN, CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 34 CM

    MDR report key: 15526761 · Received October 3, 2022

    Report

    Report Number
    0009613350-2022-00508
    Event Type
    Injury
    Date Received
    October 3, 2022
    Report Date
    November 22, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024299528
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    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). CONCOMITANT MEDICAL PRODUCTS: ZNN, CMN LAG SCREW, 10.5 MM, 120 MM INCLUDING SET SCREW ITEM#47248512010 LOT#3042375. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ITEM#47248403550 LOT#65007883. CEPHALOMEDULLARY NAIL CAP 5 MM HEIGHT ITEM#47248700205 LOT#64745428. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ITEM#47248403750 LOT#64997560. CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH ITEM#00223200418 LOT#65046164. REPORT SOURCE- GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 - 00509. CURRENTLY STILL IMPLANTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCTS WERE RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT 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. H3 OTHER TEXT : CURRENTLY STILL IMPLANTED.

    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 NOT HEALED DUE TO THE LOOSENING AND CONSTANT MOVEMENTS. 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627957 ZNN, CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 34 CM HIP INTERNAL FIXATION SYSTEM HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3020635 00889024299528

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other