BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLOC 133 MP SP T1 PPS HO 5X95

    MDR report key: 25319323 · Received May 28, 2026

    Report

    Report Number
    0001825034-2026-01476
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304512979
    PMA / PMN Number
    K110400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN, EVENT OCCURRED IN (B)(6). EVALUATION OF THE PHOTOGRAPHS PROVIDED CONFIRMED THERE IS WHITE DEBRIS INSIDE THE STERILE PACKAGING WHICH IS VISUALLY CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING. ADDITIONAL EVALUATION FOUND 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 REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. 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 THAT WHILE INSPECTING CIRCULATED ITEMS, IT WAS FOUND THAT THE STERILE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358717 TLOC 133 MP SP T1 PPS HO 5X95 PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) KWA ZIMMER BIOMET, INC. 6561290 00880304512979

    Patients

    Seq Age Sex Outcome Treatment
    1