BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 FP TYPE1 PPS HO 6.0 T1

    MDR report key: 13021713 · Received December 16, 2021

    Report

    Report Number
    0001825034-2021-03352
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    September 28, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304499072
    PMA / PMN Number
    K103755
    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). REPORT SOURCE: (B)(6). VISUAL EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED IDENTIFIED THE FOLLOWING: DAMAGE TO STERILE BLISTER AND POUCH WITH DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING AND THE POROUS COATING. THE STERILITY HAS BEEN COMPROMISED FOR LOT 6222166. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. A CORRECTIVE ACTION HAS BEEN PREVIOUSLY RAISED TO IMPLEMENT IMPROVED PACKAGING CHANGES. THESE PACKAGING CHANGES WILL REDUCE THE NUMBER OF TRANSIT RELATED PACKAGING DAMAGE EVENTS. THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED DISTRIBUTOR INSPECTED CIRCULATED ITEMS AND IDENTIFIED THE STERILE PACKAGE DAMAGED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921093 TPRLC 133 FP TYPE1 PPS HO 6.0 T1 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6222166 00880304499072

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown