BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA KR TIB. LINER RIGHT #4

    MDR report key: 19510244 · Received June 11, 2024

    Report

    Report Number
    3008021110-2024-00052
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 11, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JWH
    PMA / PMN Number
    K141934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE PHYSICA KR TIBIAL LINER INVOLVED IN THE COMPLAINT, NO PRE-EXISTING ANOMALY WAS FOUND OUT ON THE 29 ITEMS BELONGING TO THE LOT NUMBER 15AT2A7 AND STERILIZATION 1600072. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) ITEMS OUT OF 29 BELONGING TO THE LOT NUMBER 15AT2A7 AND STERILIZATION 1600072 HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. NEITHER EXPLANTED COMPONENTS NOR X-RAYS WERE AVAILABLE TO BE RETRIEVED AND ANALYZED. THEREFORE, BASED ON THE FEW INFORMATION AVAILABLE, WE ARE NOT ABLE TO PERFORM ANY FURTHER INVESTIGATION. HOWEVER, CONSIDERING THAT: - CHECKING THE MANUFACTURING CHARTS, NO PRE-EXISTING ANOMALY WAS FOUND OUT - ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, NO OBVIOUS FAILURE OF THE IMPLANT WAS REPORTED. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE RELEVANT PMS DATA, THE REVISION RATE OF PHYSICA KR TIBIAL LINERS BELONGING TO THE CODES 6531.50.XXX AND 6532.50.XXX DUE TO LOOSENING AND INSTABILITY IS AROUND 0.02%. NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL REPORT.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO LOOSENING AND INSTABILITY. ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, IN THE REPORT IT IS STATED THAT "KNEE WAS LOOSE". EVEN IF THE REASON OF THE LOOSENING IS UNKNOWN, BASED ON THE INFORMATION PROVIDED, NO OBVIOUS FAILURE OF THE IMPLANT WAS REPORTED. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2019, AND DURING THAT SURGERY THE FOLLOWING COMPONENTS WERE IMPLANTED: - PHYSICAL KR FEMORAL COMPONENT #5 (PART CODE 6511.09.150, LOT 18AS06E, STERILIZATION 1900115) - PHYSICA TIBIAL PLATE #4 (PART CODE 6522.15.040, LOT 1913658, STERILIZATION 1900334) - PHYSICA KR TIBIAL LINER #4 (PART CODE 6531.50.414, LOT 15AT2A7, STERILIZATION 1600072) - PHYSICA PATELLAR PROSTHESES (PART CODE 6595.50.026, LOT 19AT0Q5, STERILIZATION 1900235) DURING THE REVISION SURGERY HEREBY REPORTED THE PHYSICA KR TIBIAL LINER PREVIOUSLY IMPLANTED WAS REPLACED WITH THE FOLLOWING COMPONENT: - PHYSICA KR TIBIAL LINER #4 (PART CODE 6531.54.420, LOT 2021269, STERILIZATION 2100050) THE PATIENT IS A FEMALE, (B)(6). THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078685 PHYSICA KR TIB. LINER RIGHT #4 PHYSICA KR LINER RIGHT #4 - H. 14 JWH LIMACORPORATE S.P.A. 6531.50.414 15AT2A7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention