BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA TT FIX. TIBIAL TRAY #5

    MDR report key: 13891913 · Received March 24, 2022

    Report

    Report Number
    3008021110-2022-00017
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    December 6, 2021
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    MBH
    PMA / PMN Number
    K201084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS OF THE DEVICE INVOLVED WERE CHECK AND NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 14 TIBIAL PLATES RELEASED WITH LOT NUMBER 2100066 STER. 2100051. THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THIS LOT NUMBER. A FINAL REPORT WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATIONS.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS OF THE DEVICE INVOLVED WERE CHECK AND NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 14 TIBIAL PLATES RELEASED WITH LOT NUMBER 2100066 STER. (B)(4). THEREFORE, WE CAN STATE THAT THEY WERE MANUFACTURED UP TO DRAWING SPECIFICATIONS AND IN LINE WITH THE RELEVANT CHECKS AND TESTS. ACCORDING TO OUR RECORDS, 11 TIBIAL PLATES WITH CODE 6521.14.050, LOT N. 2100066 HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THIS LOT NUMBER. THE EXPLANTED COMPONENT WAS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE, THEREFORE NO SPECIFIC ANALYSIS WAS PERFORMED ON IT. X-RAYS IMAGES DATED (B)(6) 2021, AND (B)(6) 2022, WERE PROVIDED TO LIMACORPORATE BY THE COMPLAINT SOURCE. NOTE: THE X-RAYS DATED (B)(6) 2021 APPEARS TO BE POST-OPERATIVE OF THE ORIGINAL SURGERY, COMPLAINT SOURCE COULD NOT CONFIRM WHICH IS THE CORRECT SURGERY DATE (ACCORDING TO COMPLAINT SOURCE'S RECORDS, IT WAS (B)(6)). THE AVAILABLE INFORMATION AND X-RAYS WERE SHARED WITH A MEDICAL CONSULTANT FOR A CLINICAL EVALUATION. HIS COMMENTS ARE REPORTED HEREAFTER: - WITH REFERENCE TO X-RAYS DATED (B)(6) 2021, HE CONCLUDED: "TIBIAL COMPONENT IS CORRECTLY PLACED WITHIN THE DEVIATION TOLERANCE, TIBIAL COMPONENT HAS A DORSAL SLOPE OF 4,9° AND LATERAL INCLINATION OF 1,9°. THE TIBIAL COMPONENT IS NOT IN FULL CONTACT WITH THE RESECTED SURFACE. THE FEMORAL COMPONENT IS IN FLEXION OF 7,1°" - WITH REFERENCE TO X-RAYS DATED (B)(6) 2021, HE CONCLUDED: "TIBIAL COMPONENT IS SUBSIDED AND MIGRATED. ACCORDING TO THE TIME INTERVAL PROM THE PRIMARY SURGERY- LESS THAN SIX WEEKS, SUCH A RAPID MOVEMENT COULD BE CAUSED ONLY DUE TO THE VERY POOR PRIMARY FIXATION OR THE SEPTIC LOOSENING." HE ALSO STATED THAT PATIENT'S AGE COMBINED WITH THE REPORTED RENAL FAILURE AND ACTIVE SMOKING, COULD HAVE CONTRIBUTED TO THE POOR PRIMARY FIXATION OF THE CEMENTLESS DEVICE. - WITH REFERENCE TO X-RAYS DATED (B)(6) 2021, HE CONCLUDED: "REVISION CEMENTED TIBIAL COMPONENT IS PLACED OF THE SAME LEVEL-NO CHANGE OF THE JOINT LINE. BONE CEMENT IS PENETRATED THROUGH THE PEG HOLES IN THE METAPHYSIS IN THE SURROUNDED TISSUES. ON THE LATERAL VIEW THERE IN ANTERIOR SLOPE- 6,2° WHICH IS COMPENSATING THE FLEXION OF THE 7,1° OF THE FEMORAL COMPONENT. THIS COULD IMPROVE THE KINEMATIC OF THE REVISION TKA." IN CONCLUSION, THE CAUSE OF THE REPORTED LOOSENING CANNOT BE DETERMINED WITH CERTAINTY, BUT ACCORDING TO OUR MEDICAL EXPERT SUCH A RAPID SUBSIDENCE AND MIGRATION OF THE IMPLANT COULD BE RELATED TO VERY POOR PRIMARY FIXATION OR TO SEPTIC LOOSENING. THIS EVENT IS CLASSIFIED AS NOT PRODUCT RELATED. PMS DATA: LIMACORPORATE IS NOT AWARE OF ANY OTHER CASE OF KNEE REVISION SURGERY DUE TO LOOSENING OF PHYSICA TT TIBIAL PLATES (CODES 6521.14.XXX). NO CORRECTIVE ACTION NEEDED FOLLOWING THIS COMPLAINT, LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO LOOSENING OF THE OF PHYSICA TT TIBIAL PLATE (PRODUCT CODE 6521.14.050, LOT 2100066), AFTER 45 DAYS FROM THE ORIGINAL SURGERY. REVISION SURGERY DATE IS (B)(6), 2021, PREVIOUS SURGERY DATE IS (B)(6), 2021. THIS INCIDENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO LOOSENING OF THE OF PHYSICA TT TIBIAL PLATE (PRODUCT CODE 6521.14.050, LOT N. 2100066), AFTER 45 DAYS FROM THE ORIGINAL SURGERY. REVISION SURGERY DATE IS (B)(6) 2021, PREVIOUS SURGERY DATE IS (B)(6) 2021. DURING THE REVISION SURGERY, ONLY THE TIBIAL PLATE WAS REMOVED AND REPLACED WITH A PHYSICA TIBIAL COMPONENT (CODE AND LOT ARE NOT KNOWN). PATIENT WAS BORN IN (B)(6), MALE, 1.72 M, 80KG, ACTIVE SMOKER. COMPLAINT SOURCE REPORTED THAT THE PATIENT IS AFFECTED BY RENAL FAILURE AND HAS A PACEMAKER. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310768 PHYSICA TT FIX. TIBIAL TRAY #5 PHYSICA TT TIBIAL PLATE #5 MBH LIMACORPORATE SPA 6521.14.050 2100066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention