BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R+G

    MDR report key: 21557328 · Received March 10, 2025

    Report

    Report Number
    3006406161-2025-03071
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    January 23, 2025
    Report Date
    March 10, 2025
    Manufacturer
    HERAEUS MEDICAL GMBH
    Product Code
    MBB
    PMA / PMN Number
    K202475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT RECEIVED A REVISION KNEE ARTHROPLASTY IN (B)(6) 2022. A PERSONA KNEE SYSTEM WAS REVISED. AND AN ATTUNE REVISION KNEE SYSTEM WITH A ROTATING TIBIAL BASE USING PALACOS R+G 2X20 AND 2X40 WAS IMPLANTED. SUBSEQUENTLY, ON (B)(6)2025 THE ATTUNE REVISION KNEE SYSTEM DUE TO DEBONDING BETWEEN THE BONE CEMENT AND THE KNEE IMPLANT. THE BATCH RECORD REVIEW OF THE BATCH IN QUESTION DID NOT REVEAL ANY ABNORMALITIES. THE FACT THAT THE BONE CEMENT WAS STILL WELL ADHERED TO THE BONE INDICATES THAT THERE WAS NO ISSUE WITH THE BONE CEMENT QUALITY OR THE HANDLING.

    Description of Event or Problem · 0

    ASEPTIC LOOSENING OF THE RIGHT TKA (TOTAL KNEE ARTHROPLASTY): REMOVAL OF THE ATTUNE TKA PLACED IN (B)(6) 2022 AND PLACEMENT OF A PERSONA REVISION PROSTHESIS. THE PROSTHESIS DID NOT ADHERE TO THE CEMENT. MANUFACTURER / ARTICLE NO. / LOT / DESCRIPTION JOHNSON & JOHNSON / 150440205 / JP4451 / ATTUNE CRS FEMORAL RT SZ 5 CEM. JOHNSON & JOHNSON / 150660004 / 3790961 / ATTUNE REV RP TIB BASE SZ 4 CEM. JOHNSON & JOHNSON / 151710508 / 9337433 / ATTUNE CRS RP INSRT SZ 5 8MM. JOHNSON & JOHNSON / 151820035 / 3945091 / ATTUNE® MEDIAL PATELLA DOME, SIZE 35 MM. JOHNSON & JOHNSON / 151214050 / D22030470 / ATTUNE® CEMENTED STEM, SIZE 14 X 50MM. JOHNSON & JOHNSON / 152303001 / J12G45 / ATTUNE TIB AUG UNIV SZ 3/4 5MM. MEDTRONIC (SWITZERLAND) SA / 103020OST / 2206103701 / ALLOGRAFT BONE BLOCK 17X20X30MM. HERAEUS MEDICAL / 66017747 / 62261139 / PALACOS R+G 2X40. HERAEUS MEDICAL / 66017775 / 60225325 / PALACOS R+G 2X20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144281 PALACOS R+G BONE CEMENT, MEDICATED MBB HERAEUS MEDICAL GMBH 60225325

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention