BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS SIDE EXP DSTL FMRL LT 15CM

    MDR report key: 23010371 · Received September 9, 2025

    Report

    Report Number
    0001825034-2025-02855
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 19, 2025
    Report Date
    January 23, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304654419
    PMA / PMN Number
    K140509
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HAVE BEEN UPDATED: B4; B5; G3; H2; H3; H6; H10; H11. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ON THE LATER IMAGE, THERE ARE INCREASED RADIOLUCENT LINES AT THE COMPRESS SPINDLE METAL BONE INTERFACE, CONSISTENT WITH THE REPORTED UNFIXED (LOOSE) SPINDLE. ALSO ON THE LATER IMAGE, THE LONG AXIS OF THE EXPOSED ANCHOR PLUG TRACTION BAR IS NO LONGER PARALLEL TO THE SPINDLE BUT RATHER HAS A SLIGHT TILT WHICH IS A FINDING CONSISTENT WITH A BROKEN TRACTION BAR. THE SEGMENTAL DISTAL FEMUR COMPONENT HAS MOVED DOWN EXPOSING A GREATER LENGTH OF THE EXPANDER SECTION ON THE LATER IMAGE. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED RADIOGRAPHS. ROOT CAUSE WAS UNABLE TO 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). D6: IMPLANT DATE - 2022. D10: CONCOMITANT MEDICAL PRODUCTS: 178363 - CPS XS SHT SPDL W PINS - 235950, 178552 - CPS SHORT ANCHOR PLUG - 952730, 178526 - CPS TRANSVERSE PIN - 297740, 161035 - OSS RS AXLE - 538210, 161034 - OSS RS POLY FEM BUSHING - 738370, 161037 - OSS RS NON-MOD PLATE - 589350, 150476 - OSS POLY TIBIAL BUSHING - 148090, 161094 - OSS RS 12MM LS TIBIAL BEARING - 622880, 150493 - OSS REINFORCED YOKE - 827180, 150478 - OSS POLY LOCK PIN - 148110, 178512 - CPS NUT CO-CR-MO ALLOY - 144930. H6: COMPONENT CODE: MECHANICAL (G04) - FEMUR. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING 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 AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PAIN OVER A SPAN OF THE LAST YEAR. THE SURGEON BELIEVED THE EXPANDABLE COMPONENT WAS EXPANDING ON ITS OWN, WITHOUT THE REQUIRED SURGERY TO EXPAND IT. THE PATIENT FELT A POP AND COULD NOT BEAR WEAR. THE PATIENT WAS THEN REVISED APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO A BROKEN ANCHOR PLUG AND THE SPINDLE LOST BONE IN-GROWTH AT THE BONE INTERFACE AND WAS NO LONGER FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168377 OSS RS SIDE EXP DSTL FMRL LT 15CM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. 270650 00880304654419

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Hospitalization| R SEE H11 NARRATIVE.