BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS CMNTD PROX TIB STEM 11X150

    MDR report key: 22385135 · Received July 2, 2025

    Report

    Report Number
    0001825034-2025-01944
    Event Type
    Injury
    Date Received
    July 2, 2025
    Report Date
    November 4, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304239661
    PMA / PMN Number
    K123501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: (B)(6), OSS POLY TIBIAL BUSHING, LOT: 66090337, (B)(6), OSS REINFORCED YOKE, LOT: 65889383, (B)(6), OSS TIBIAL POLY BEARING 12MM, LOT: 65803951, (B)(6), OSS 5CM DIAPHYSEAL SEGMENT, LOT: 080620, (B)(6), OSS 9CM PROX TIB MOD COCR, LOT: 064520R, (B)(6), OSS POLY FEMORAL BUSHINGS, LOT: 65935670, (B)(6), OSS POLY LOCK PIN, LOT: 65974062, (B)(6), OSS AXLE, LOT: UNKNOWN. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. 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.

    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.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158853 OSS CMNTD PROX TIB STEM 11X150 PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. 179110 00880304239661

    Patients

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