BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 17.0

    MDR report key: 20359724 · Received October 3, 2024

    Report

    Report Number
    0001825034-2024-02326
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    September 13, 2024
    Report Date
    January 13, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304514416
    PMA / PMN Number
    K110400
    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: B4; D9; G3; H2; H3; H6. PRODUCT WAS RETURNED AND EVALUATED. VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (BLISTER). STERILITY HAD NOT BEEN COMPROMISED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. THE REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. 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. THE REPORTED EVENT HAS BEEN CONFIRMED BY EVALUATION OF THE RETURNED PRODUCT AND PROVIDED PHOTOS. 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: 51-107200 TPRLC 133 MP TYPE1 PPS HO 20.0 6612209; 51-104170 TPRLC 133 T1 PPS HO 17X154MM 6971788; 51-105170 TPRLC XR T1 PPS 17X154MM 7206104. 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 FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CIRCULATED ITEMS HAD DAMAGE TO THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136746 TPRLC 133 MP TYPE1 PPS SO 17.0 PROSTHESIS, HIPS KWA ZIMMER BIOMET, INC. N/A 7027144 00880304514416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown