BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 17.0

    MDR report key: 9953458 · Received April 13, 2020

    Report

    Report Number
    0001825034-2020-01613
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Date of Event
    November 28, 2019
    Report Date
    April 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 51-107150 TPRLC 133 MP TYPE1 PPS HO 15.0 LOT#: 6130002. (B)(6). THE EVENT WAS CONFIRMED WITH PRODUCT RECEIVED. EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED CONFIRMED THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER AND THE STERILE PACKAGING (BLISTER AND FOAM INSERT) IS DAMAGED. STERILE BARRIER WAS NOT COMPROMISED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IT LIKELY TO BE DAMAGE DURING TRANSIT. A CORRECTIVE ACTION WAS OPENED TO ASSESS ALL CURRENT STERILE BARRIER SYSTEMS USED TO PACKAGE PRODUCTS AT ZIMMER BIOMET BRIDGEND. AS PART OF THIS ACTION, THE POUCH IS BEING IMPROVED TO USE A STRONGER MATERIAL (NYLON), AND FOAM END CAPS ARE BEING ADDED. ALSO, THE ORIENTATION THE DEVICES ARE PACKED IN THE SHIPPER BOX IS MOVING FROM VERTICAL TO HORIZONTAL, AND THE THICKNESS OF THE SHIPPER BOX HAS BEEN INCREASED. 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: 0001825034-2020-01612.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. UPON INSPECTION BY THE MANUFACTURER, STERILE BARRIER WAS INTACT, HOWEVER, DEBRIS WAS FOUND IN THE STERILE PACKAGING. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416298 TPRLC 133 MP TYPE1 PPS HO 17.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6114773

    Patients

    Seq Age Sex Outcome Treatment
    1