BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA FIXED TIBIAL PLATE #7

    MDR report key: 16494904 · Received March 7, 2023

    Report

    Report Number
    3008021110-2023-00020
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    April 6, 2022
    Report Date
    April 16, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JWH
    PMA / PMN Number
    K141934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 32 TIBIAL PLATES RELEASED WITH LOT NUMBER 2024249. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER (2024249). WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 32 TIBIAL PLATES RELEASED WITH LOT NUMBER 2024249. ACCORDING TO OUR RECORDS, AT LEAST 30 OUT OF 32 WITH LOT 2024249 - STER. 2100070 HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. EVEN THOUGH REQUESTED NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE NOT PROVIDED BY COMPLAINT SOURCE. THE EXPLANTS INVOLVED WERE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. THE PRESENCE OF CEMENT ON TIBIAL AND FEMUR COMPONENT IS VISIBLE, BUT WITHOUT THE ACCESSIBILITY AND ANALYSIS OF X-RAYS IT IS NOT POSSIBLE TO REACH A CONCLUSION. BASED ON THE AVAILABLE INFORMATION, WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE FOR THE EVENT. THE CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO PRE-EXISTING ANOMALIES ON COMPONENTS MANUFACTURED LOT. NR. LOT 2024249 - STER. 2100070, THEREFORE WE CAN STATE THEY HAVE BEEN MANUFACTURED UP TO SPECIFICATIONS AND IN LINE WITH RELEVANT TESTS AND CHECKS. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF PHYSICA FIXED TIBIAL PLATE (FAMILY CODE: 6522.15.XXX) DUE TO LOOSENING IS 0,02%. ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL MDR REPORT.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO LOOSENING OF THE PHYSICA FIXED TIBIAL PLATE #7 (PRODUCT CODE 6522.15.070, LOT 2024249, STER. 2100070). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2022, THE PREVIOUS SURGERY ON 12TH JANUARY 2021. PATIENT DATA: MALE, 53 YEARS OLD, 175 CM, 90 KG, VERY ACTIVE. THIS EVENT OCCURRED IN GERMANY.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO LOOSENING OF THE PHYSICA FIXED TIBIAL PLATE #7 (PRODUCT CODE 6522.15.070, LOT 2024249, STER. 2100070). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2022. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021, DIAGNOSIS OF "ADVANCED PANGONARTHROSIS ON THE RIGHT SIDE". PATIENT DATA: MALE, 53 YEARS OLD, 175 CM, 90 KG, VERY ACTIVE. THIS EVENT OCCURRED IN GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85469 PHYSICA FIXED TIBIAL PLATE #7 TIBIAL PLATE #7 JWH LIMACORPORATE S.P.A. 6522.15.070 2024249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention