BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AVL TIBIAL LOCK RING

    MDR report key: 24876216 · Received April 14, 2026

    Report

    Report Number
    0001825034-2026-00948
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304456181
    PMA / PMN Number
    K051570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 161075 - OSS AVL YOKE 12 MM - 504520, 161071 - OSS AVL POLY TIB BUSHING SET - 65904793, 161094 - OSS RS 12, MM LS TIBIAL BEARING - 66676165, 150478 - OSS POLY LOCK PIN - 67073891, 161034 - OSS RS POLY FEM BUSHINGS SET/2 - 67221201, 161035 - OSS RS AXLE - 67286405, 161124 - OSS RS 8.5 CM SEG FMRL LEFT - 66759350, 150464 - OSS 3 CM DIAPHYSEL SEGMENT - 724570, 150461 - OSS 3 CM ELLIP DIAPHYSEAL SEG - 65725118, 150375 - OSS CEMENTED IM STEM 15 X 225 - 338670, CP113459 - OSS RS AVL 9 CM PROX TIB MOD - 717320, 150362 - OSS CEMENTED IM STEM 13 MM X 90 MM - 808790. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. APPROXIMATELY 9 MONTHS POST-OP, THE PATIENT WAS REVISED DUE TO THE AVL LOCKING RING BREAKING RESULTING IN A DISLOCATION OF THE PROSTHESIS. THE AVL BEARING ASSEMBLY WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937460 OSS AVL TIBIAL LOCK RING PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. 006520 00880304456181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H