BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC

    MDR report key: 7479608 · Received May 2, 2018

    Report

    Report Number
    0001825034-2018-03091
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 4, 2018
    Report Date
    December 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE BLISTERS HAD PROTRUSION/DENTS FROM THE IMPLANT MOVEMENT. THE STERILITY HOWEVER WAS NOT COMPROMISED. THE SEAL WAS STILL INTACT WHEN PRODUCTS WERE RECEIVED FOR INVESTIGATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03090 - 2.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). REPORTER HAD INDICATED THAT PRODUCT WILL BE RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2018-03090.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGE OF THE DEVICE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322890 TAPERLOC HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 6227972

    Patients

    Seq Age Sex Outcome Treatment
    1