BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 16X152MM

    MDR report key: 23657824 · Received November 26, 2025

    Report

    Report Number
    0001825034-2025-03801
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 10, 2025
    Report Date
    April 6, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304491854
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D9; G3; H2; H3; H6; H10. LOT 7220801: VISUAL EVALUATION OF THE RETURNED PRODUCT/PROVIDED PHOTOS IDENTIFIED DAMAGE TO THE STERILE PACKAGING (POUCH). STERILITY HAS BEEN COMPROMISED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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 TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DAMAGED STERILE PACKAGING WAS IDENTIFIED DURING INSPECTION OF CIRCULATED STOCK ITEMS. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568888 TPRLC 133 T1 PPS HO 16X152MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 7220801 00880304491854

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown