BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK PRI TIB TRAY 79MM

    MDR report key: 19499305 · Received June 10, 2024

    Report

    Report Number
    0001825034-2024-01534
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    May 13, 2024
    Report Date
    November 27, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBV
    PMA / PMN Number
    K010212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 MEDICAL DEVICES: MAXIM PRI DCM TIB BRNG10X79/83MM CATALOG#: 11-146170 LOT#: 751950. MAXIM ILOK ANA PRI FEMORAL 70 LT CATALOG#: 140033 LOT#: 900010. BIOMET FINNED PRI STEM 40MM CATALOG#: 141314 LOT#: 775900. BMET ARCOM AP PAT W/WIRE 37MM CATALOG#: 11-150830 LOT#: 753510. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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. UPDATED: B4, B5, G3, G6, H2, H3, H6, H10, AND H11. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SEVERE RIGHT KNEE ARTHROPLASTY VARUS MALALIGNMENT WITH METAL-ON-METAL MEDIAL COMPARTMENT CONTACT FROM SEVERE POLYETHYLENE WEAR. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATIONS. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY EIGHTEEN (18) YEARS POST-IMPLANTATION DUE TO TIBIAL INSERT WEAR AND BLACK SYNOVIAL TISSUE. THE TIBIAL INSERT WAS REMOVED AND REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY EIGHTEEN (18) YEARS POST-IMPLANTATION DUE TO TIBIAL INSERT WEAR AND BLACK SYNOVIAL TISSUE. THE TIBIAL INSERT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148690 BIOMET ILOK PRI TIB TRAY 79MM PROSTHESIS, KNEE MBV ZIMMER BIOMET, INC. N/A 917420

    Patients

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