BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 11.0

    MDR report key: 12167776 · Received July 14, 2021

    Report

    Report Number
    0001825034-2021-02108
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 21, 2021
    Report Date
    September 30, 2021
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; D9; G3; H2; H3; H4; H6 EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED FOR LOT 6954325 CONFIRMED FOREIGN DEBRIS IS PRESENT INSIDE THE STERILE PACKAGING, AND THE STERILE PACKAGING REMAINS SEALED. 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 DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS THE OPERATOR NOT FOLLOWING THE PROVIDED WORK INSTRUCTIONS DURING MANUFACTURING. 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 ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE (B)(6). PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE 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 - 2021 - 02104, 0001825034 - 2021 - 02105, 0001825034 - 2021 - 02106, 0001825034 - 2021 - 02107, 0001825034 - 2021 - 02109.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING WAREHOUSE INSPECTION, DEBRIS WAS FOUND IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. 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
    1062053 TPRLC 133 MP TYPE1 PPS SO 11.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6954325

    Patients

    Seq Age Sex Outcome Treatment
    1