BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AVL YOKE 16MM

    MDR report key: 20976602 · Received December 19, 2024

    Report

    Report Number
    0001825034-2024-03019
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    December 17, 2024
    Report Date
    January 21, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K051570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. NOT REPORTABLE - UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS DEVICE DID NOT FRACTURE AND DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. 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 : 161071 - OSS AVL POLY TIB BUSHING SET - 571250; 161073 - OSS AVL TIBIAL LOCK RING - 385830; 161096 - OSS RS 16MM LS TIBIAL BEARING - 117880; 150478 - OSS POLY LOCK PIN - 483560; 161034 - OSS RS POLY FEM BUSHINGS SET/2 - 685770; 161035 - OSS RS AXLE - 898060. G2 : FOREIGN COUNTRY : EUROPE : BELGIUM. 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY AND APPROXIMATELY 3 YEARS POST-OP, WAS REVISED DUE TO SUBLUXATION AND DISASSOCIATION OF THE TIBIAL COMPONENTS AND FRACTURE OF THE LOCKING RING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023310 OSS AVL YOKE 16MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 400420

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Hospitalization| R SEE H11.