BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 24080826 · Received January 15, 2026

    Report

    Report Number
    0001825034-2026-00148
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    January 23, 2025
    Report Date
    April 20, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304240094
    PMA / PMN Number
    K052685
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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; D2; G1; G3; G6; H1; H2; H3; 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 THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. 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

    (B)(4). D10: 150427 - OSS TIB BLK AUG 10X71/75 UNIV - 472460. 150444 - OSS CMNTD PROX TIB STEM 9 X150 - 402700. 150422 - OSS MOD TIB BASEPLATE 71MM - 852790. 150366 - OSS CEMENTED IM STEM 12X150 - 402620. 161012 - OSS RS 7 CM MOD SEG FMRL-LT - 827790. 150461 - OSS 3CM ELLIP DIAPHYSEAL SEG - 368600. 161034 - OSS RS POLY FEM BUSHINGS SET/2 - 800260. 150478 - OSS POLY LOCK PIN - 148130. 161035 - OSS RS AXLE - 625660. 150476 - OSS POLY TIBIAL BUSHING - 454800. 150412 - OSS TIBIAL POLY BEARING 16MM - 793750. 66044274 - PALACOSPRO 75G - A124. 66044274 - PALACOSPRO 75G - A125. G2 : FOREIGN COUNTRY : SPAIN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 3 YEARS POST-OP, THE PATIENT SUFFERED A YOKE FRACTURE AND WAS SUBSEQUENTLY REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145313 OSS REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. 105020 00880304240094

    Patients

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