BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 22385124 · Received July 2, 2025

    Report

    Report Number
    0001825034-2025-01942
    Event Type
    Injury
    Date Received
    July 2, 2025
    Report Date
    November 4, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304240094
    PMA / PMN Number
    K052685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, H2, H3, H6, H10. THE FOLLOWING SECTION WAS CORRECTED: H4. THE REPORTED EVENT COULD NOT BE CONFIRMED. NO DEVICES OR PHOTOGRAPHS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. X-RAY IMAGES WERE RECEIVED AND COULD NOT BE REVIEWED BY A HEALTHCARE PROFESSIONAL, AS THE IMAGES WERE NOT DATED AND FULL CONSTRUCT WAS NOT VISIBLE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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: 150476, OSS POLY TIBIAL BUSHING, LOT 66090337. 150410, OSS TIBIAL POLY BEARING 12MM, LOT 65803951. 150445, OSS CMNTD PROX TIB STEM 11X150, LOT 179110. 150465, OSS 5CM DIAPHYSEAL SEGMENT, LOT 080620. CP113462, OSS 9CM PROX TIB MOD COCR, LOT 064520R. 150477, OSS POLY FEMORAL BUSHINGS, LOT 65935670. 150478, OSS POLY LOCK PIN, LOT 65974062. 150480, OSS AXLE, LOT UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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 ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT IMPLANTATION OF ZIMMER BIOMET DEVICES ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT HAS BEEN INDICATED FOR A POSSIBLE REVISION DUE TO PAIN IN THE TIBIAL REGION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204751 OSS REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. 65889383 00880304240094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11 NARRATIVE.