BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 PPS SO 15.0

    MDR report key: 7775060 · Received August 10, 2018

    Report

    Report Number
    0001825034-2018-04466
    Event Type
    Injury
    Date Received
    August 10, 2018
    Report Date
    January 3, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). MEDICAL DEVICES: ITEM # 11-363661, HEAD, LOT # 439230, ITEM # 01000780, LINER, LOT # 6014189, ITEM # 01000664, SHELL, LOT # 6028983. MULTIPLE REPORTS ARE BEING SUBMITTED FOR THIS EVEN. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-04459, 0001825034-2018-04467, 0001825034-2018-04464.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS BEEN EXPERIENCING PAIN FOR APPROXIMATELY 1 YEAR POST IMPLANTATION. TESTED NEGATIVE FOR INFECTION. LAB WORK FOR METAL ALLERGY BEING DISCUSSED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615627 TPRLC 133 TYPE1 PPS SO 15.0 HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 3899138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other