BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 CM

    MDR report key: 12141672 · Received July 9, 2021

    Report

    Report Number
    0009613350-2021-00338
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 24, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024299504
    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

    PLEASE INVALIDATE THIS MEDWATCH REPORT AS THE MEDICAL DEVICE HAS BEEN VOIDED. THE EVENT RELATED TO THE CASE (B)(4) IS FURTHER REPORTED UNDER 0009613350-2021-00341. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PLEASE INVALIDATE THIS MEDWATCH REPORT AS THE MEDICAL DEVICE HAS BEEN VOIDED. THE EVENT RELATED TO THE CASE (B)(4) IS FURTHER REPORTED UNDER 0009613350-2021-00341.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW; CATALOG #: 47-2485-090-10; LOT#: 2968566. THERAPY DATE: (B)(6) 2021. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE. DURING THE SURGERY, SINCE THE FEMORAL NECK SCREW AND BOTH LIPS GOT FRACTURED, THE DEVICES COULD NOT BE EXPLANTED. THERE WAS A SURGICAL DELAY OF 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041564 CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2963206 00889024299504

    Patients

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