BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK PRI TIB TRAY 79MM

    MDR report key: 20727358 · Received November 19, 2024

    Report

    Report Number
    0001825034-2024-02740
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    November 8, 2024
    Report Date
    April 29, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D2, D4, G1, G3, G6, H1, H2, H3, H6, AND H11. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS WERE NOT PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. RADIOGRAPHS WERE PROVIDED AND ASSESSED BUT NOT SENT FOR MMI. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE ROOT CAUSE CAN BE ATTRIBUTED TO THE USE OF INCOMPATIBLE IMPLANTS, IF THE BEARING 183422 (63/67MM) WAS USED WITH 141215 (79MM) TIBIAL TRAY THE BEARING WOULD NOT BE SECURELY CAPTURED ON THE TRAY. THIS INCOMPATIBILITY COULD DAMAGE THE BEARING AND RESULT IN EXCESSIVE WEAR, DAMAGE AND FRACTURE OF THE BEARING. THIS COMPLAINT IS CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE.TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10-MEDICAL PRODUCT VNGD CR TIB BRG 12X63/67. ITEM# 183422. LOT# B416540. BIOMET TIBIAL LOCKING BAR. ITEM# 141205. LOT# 66365811. VNGD ANT STBLZD BRG 16X67. ITEM# 189046. LOT# 66347376. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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 A PATIENT WAS REVISED DUE TO LIGAMENT LAXITY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421779 BIOMET ILOK PRI TIB TRAY 79MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

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