BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 16X152MM

    MDR report key: 20128840 · Received September 3, 2024

    Report

    Report Number
    0001825034-2024-02139
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 15, 2024
    Report Date
    January 7, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304491854
    PMA / PMN Number
    K200196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-02140; 0001825034-2024-02141; 0001825034-2024-02142. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (BLISTER). STERILITY HAS BEEN COMPROMISED. THE EVENT IS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED PRODUCT AND PROVIDED PHOTOS. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONSIDERED CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO TRANSIT DAMAGE AND A PACKAGING DESIGN ISSUE. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 51-107120 TPRLC 133 MP TYPE1 PPS HO 12.0 6232309, 51-104160 TPRLC 133 T1 PPS HO 16X152MM 7130685, 51-105160 TPRLC XR T1 PPS 16X152MM 7136707. G2: FOREIGN: JAPAN. 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 · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSPECTED STOCK ITEMS HAD DAMAGE TO THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833338 TPRLC 133 T1 PPS HO 16X152MM PROSTHESIS, HIPS LZO ZIMMER BIOMET, INC. N/A 7130643 00880304491854

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE