BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC XR T1 PPS 14X148MM MM T1

    MDR report key: 10194496 · Received June 25, 2020

    Report

    Report Number
    0001825034-2020-02509
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    June 2, 2020
    Report Date
    September 23, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K120030
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED CONFIRMED THE FOLLOWING: LOT #2602026; 3122174; 3564651; 3237407: DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. LOT #3406199; 3391427: DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF THE POROUS COATING AND FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. THE REPORTED EVENT IS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE LIKELY CONDITION OF THE PRODUCT WHEN IT LEFT ZIMMER BIOMET WAS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE. THIS REPORTED EVENT FALLS WITHIN THE SCOPE OF A PREVIOUS CORRECTIVE ACTION, THE PURPOSE OF WHICH IS TO ASSESS ALL CURRENT STERILE BARRIER SYSTEMS USED TO PACKAGE PRODUCTS AT ZIMMER BIOMET BRIDGEND. AS PART OF THIS, 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. UPON FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE PACKAGING MEETS THE ACCEPTABLE CRITERIA SPECIFICATIONS AND THE STERILITY HAS NOT BEEN BREACHED. THIS EVENT IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THE INITIAL REPORT SHOULD BE VOIDED. 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). REPORT SOURCE: (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS WAS IDENTIFIED IN THE STERILE PACKAGING WHILE INVESTIGATING ITEMS IN STOCK. NO PATIENTS WERE INVOLVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659296 TPRLC XR T1 PPS 14X148MM MM T1 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 3564651

    Patients

    Seq Age Sex Outcome Treatment
    1