BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS NUT CO-CR-MO ALLOY

    MDR report key: 22954772 · Received September 3, 2025

    Report

    Report Number
    0001825034-2025-02772
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 5, 2025
    Report Date
    January 13, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304260399
    PMA / PMN Number
    K043547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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; B5; D2; G1; G3; G6; H1; H2; H3; H4; H6. THE EVENT CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, E4, G3, H2, H6, H10. THIS REPORT IS BEING SUBMITTED TO NOTATE THAT THE HOSPITAL ALLEGEDLY REPORTED THE EVENT AS WELL UNDER REFERENCE (B)(4). 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: 178404, CPS ANCHOR PLUG 14MM, LOT 65740293. 178528, CPS TRANSVERSE PIN 6PK 36MM, LOT 197750. 178538, CPS CENTERING SLEEVE 16MM, LOT 223560. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AFFECTED LIMB WAS OF THE LEFT LATERALITY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A TRANSFEMORAL AMPUTATION RECEIVED A STUDY TRANSDERMAL COMPRESS SYSTEM AND WAS FULL WEIGHT BEARING APPROXIMATELY 6 MONTHS LATER. SUBSEQUENTLY, THE PATIENT PRESENTED WITH PAIN APPROXIMATELY 9 MONTHS POST IMPLANTATION, AND IT WAS NOTED THAT THE DEVICES WERE LOOSE. THE PATIENT UNDERWENT A REVISION SURGERY 1 WEEK AFTER FINDING OF LOOSENING. ATTEMPTS HAVE BEEN MADE, AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234241 CPS NUT CO-CR-MO ALLOY PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. 66469877 00880304260399

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.