BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR T1 PPS 17X154MM

    MDR report key: 8195728 · Received December 26, 2018

    Report

    Report Number
    0001825034-2018-11477
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    December 4, 2018
    Report Date
    July 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K120030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE FOAM TO SHED. 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 IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 51-105150, STEM, LOT 2931354, 51-105150, STEM, LOT 2867448. EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 11475, 0001825034 - 2018 - 11476.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION, IT WAS FOUND THAT THE STERILE PACKAGING WAS DAMAGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036979 TPRLC XR T1 PPS 17X154MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 2884107

    Patients

    Seq Age Sex Outcome Treatment
    1