BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 13X146MM 6MM T1

    MDR report key: 10208902 · Received June 29, 2020

    Report

    Report Number
    0001825034-2020-02564
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 9, 2020
    Report Date
    September 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304489738
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY EXAMINATION OF THE DEVICES/PHOTOGRAPHS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE. EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED CONFIRMED THE FOLLOWING: LOT #2901608; 3791225; 3090879; 2955965; 3473486; 3458643: DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. LOT #3383473; 3560787: 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IN THE STERILE PACKAGING MEETS THE ACCEPTABLE CRITERIA AND PRODUCT IS CONFORMING TO SPECIFICATIONS. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IN THE STERILE PACKAGING MEETS THE ACCEPTABLE CRITERIA AND PRODUCT IS CONFORMING TO SPECIFICATIONS. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED.

    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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02558, 0001825034-2020-02559, 0001825034-2020-02560, 0001825034-2020-02561, 0001825034-2020-02562, 0001825034-2020-02563, 0001825034-2020-02565.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674027 TPRLC 133 T1 PPS HO 13X146MM 6MM T1 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3458643 00880304489738

    Patients

    Seq Age Sex Outcome Treatment
    1