BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB PP DISTAL FEMUR TRAUMA IMPLANT

    MDR report key: 8631812 · Received May 22, 2019

    Report

    Report Number
    0009613350-2019-00320
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    May 15, 2019
    Report Date
    July 25, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. TREND ANALYSIS: ANALYSIS COULD NOT BE PERFORMED AS NO ITEM NUMBERS IS/ARE AVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PRODUCT IMPLANTED ON UNKNOWN DATE AND REMOVED ON (B)(6) 2019 DUE TO FRACTURED NCB PP DISTAL FEMUR. REVIEW OF RECEIVED DATA: THERE IS 1 X-RAY (UNDATED) AVAILABLE. THE X-RAY CONFIRMS THE BREAKAGE OF THE PLATE. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. CONCLUSION: IT WAS REPORTED THAT THE PRODUCT IMPLANTED ON UNKNOWN DATE AND REMOVED ON (B)(6) 2019 DUE TO FRACTURED NCB PP DISTAL FEMUR. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. NEITHER OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. THE X-RAY RECEIVED CONFIRMS THAT THE PLATE IS BROKEN. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). HOWEVER, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. NEW INFORMATION RECEIVED: EXPLANTATION DATE, EVENT DATE, DATE RECEIVED BY MANUFACTURER, X-RAY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PLEASE REFER TO REPORT 0009613350-2019-00320-1.

    Description of Event or Problem · 0

    NO CHANGE TO EVENT DESCRIPTION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN, LOT# UNKNOWN, NCBPP DISTAL FEMUR TRAUMA IMPLANT. PMA/510K: THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K100111. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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). DEVICE EVALUATED BY MFR: UNKNOWN PRODUCT IDENTIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426647 NCB PP DISTAL FEMUR TRAUMA IMPLANT N/A HRS ZIMMER GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R