BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AVL POLY TIB BUSHING SET

    MDR report key: 20976754 · Received December 19, 2024

    Report

    Report Number
    0001825034-2024-03020
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    August 12, 2021
    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

    (B)(4). D10: 161073 - OSS AVL TIBIAL LOCK RING - (B)(6). CP0000901 - AVL RS TIBIAL BEARING SET - (B)(6) G2: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT HAS BEEN DISCARDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS DEVICE DID NOT DISLOCATE AND WAS FRACTURED DURING EXTRACTION. THE DEVICE INVOLVED IN THE EVENT WILL BE CAPTURED UNDER 0001825034-2024-03022. 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 THE PATIENT UNDERWENT A KNEE SURGERY. APPROXIMATELY 2 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO A FRACTURED LOCKING RING AND TIBIAL BUSHING, POLY WEAR, AND LUXATION OF THE POLY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084096 OSS AVL POLY TIB BUSHING SET PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 594260

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization| R SEE H11.