BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC COMPLETE

    MDR report key: 22778712 · Received August 11, 2025

    Report

    Report Number
    0001825034-2025-02407
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 15, 2025
    Report Date
    September 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304498174
    PMA / PMN Number
    K103755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CMP-1001179 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6; H10. LOTS 70455928; 6866846; 6639730; VISUAL EVALUATION OF THE RETURNED PRODUCTS 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 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. THE REPORTED EVENT HAS BEEN CONFIRMED BY EVALUATION OF THE RETURNED PRODUCTS. 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 DURING STOCK INSPECTION, THE INNER PACKAGING WAS FOUND BREACHED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183069 TAPERLOC COMPLETE PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 7045928 00880304498174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown