BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC STANDARD OFFSET FEMORAL STEM

    MDR report key: 7491482 · Received May 7, 2018

    Report

    Report Number
    0001825034-2018-03209
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 10, 2018
    Report Date
    April 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE CAVITIES CONFIRMED THERE IS DEBRIS WITHIN THE SEALED CAVITIES. ALL PACKAGE SEALS WERE INTACT WHEN THEY WERE RECEIVED FOR INVESTIGATION. FTIR ANALYSIS OF THE DEBRIS FOR ITEM # 51-103110 AND LOT # 6191428 CONCLUDED THAT IT IS MADE UP OF A POLYPROPYLENE AND AN ADDITIVE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT IS THE OPERATOR NOT FOLLOWING INSTRUCTIONS DURING THE MANUFACTURING PROCESS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING WAS FOUND TO HAVE DEBRIS IN IT. THIS WAS FOUND DURING PRODUCT INSPECTION AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334665 TAPERLOC STANDARD OFFSET FEMORAL STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6191428

    Patients

    Seq Age Sex Outcome Treatment
    1