BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 38 CM

    MDR report key: 11854096 · Received May 20, 2021

    Report

    Report Number
    0009613350-2021-00228
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 20, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024299870
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT REPORT IS BEING SUBMITTED AS A REPLACEMENT OF 0001822565-2021-00784 SUBMITTED BY (B)(6) AS THE PRODUCT DESIGN BELONGS TO WINTERTHUR. KINDLY VOID MEDWATCH REPORT 0001822565-2021-00784 AND CONSIDER THE PRESENT MEDWATCH REPORT 0009613350-2021-00228. CONCOMITANT MEDICAL PRODUCTS: TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH; CATALOG#: 47-2490-097-00; LOT#: 64867311. ZNN, CMN LAG SCREW, 10.5 MM, 110 MM INCLUDING SET SCREW; CATALOG#: 47-2485-110-10; LOT#: 2940288. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD CATALOG#: 47-2484-037-50; LOT#: 64850529. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-035-50; LOT#: 64689229. 3.0 MM THREADED PIN 305 MM LENGTH; CATALOG#: 00-2490-012-30; LOT#: UNKNOWN. ZNN, CMN THREADED PIN, 3.2 MM; CATALOG#: 00-2490-450-32; LOT#: UNKNOWN. THERAPY DATE: (B)(6) 2021. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER RECEIVED 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 THE RIGHT SIDE AND UNDERWENT A REVISION SURGERY DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754134 CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 38 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2706630R 00889024299870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R