BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE

    MDR report key: 21658056 · Received March 20, 2025

    Report

    Report Number
    0001825034-2025-00769
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    February 19, 2025
    Report Date
    August 4, 2025
    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
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: OSS POLY TIBIAL BUSHING: CATALOG#150476, LOT#173200. OSS POLY LOCK PIN: CATALOG#150478, LOT#470220. OSS RS AXLE: CATALOG#161035, LOT#258450. OSS RS POLY FEM BUSHINGS SET/2: CATALOG#161034, LOT#267650. OSS STRT COLLARED STEM 11X 150: CATALOG#150485, LOT#311760R. OSS 9CM PROX TIB MOD COCR: CATALOG#CP113462, LOT#006100. OSS RS 3CM RESURFACING LT: CATALOG#151802, LOT#163180. OSS CEMENTED IM STEM 11MMX90MM: CATALOG#150360, LOT#522010. OSS TIBIAL POLY BEARING 16MM: CATALOG#150412, LOT#859080. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, 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 HAVE BEEN UPDATED: B4; B5; G3; H2; H3; H6; H11. VISUAL INSPECTION OF THE RETURNED DEVICE EXHIBITS SIGNS OF USE (SCRATCHES) AND CONFIRMS THAT THE DEVICE HAS FRACTURED. NOT ALL FRACTURED PIECES WERE RETURNED. FRACTURED ANALYSIS OF THE RETURNED DEVICE STATES OPTICAL IMAGES OF THE DEVICE FRACTURE SURFACE SHOWED RATCHET MARKS AND FAINT BEACH MARKS ARTIFACTS IN OPPOSITE DIRECTIONS THAT SUGGESTS A FATIGUE MODE FAILURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE KNEE PROCEDURE. APPROXIMATELY FOUR (4) YEARS POST-IMPLANTATION, THE WINGS OF THE YOKE COMPONENT FRACTURED AND THE PATIENT UNDERWENT REVISION SURGERY. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339351 ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. 068030 00880304240094

    Patients

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