BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA KR TIB. LINER RIGHT #5

    MDR report key: 16022475 · Received December 21, 2022

    Report

    Report Number
    3008021110-2022-00133
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    November 14, 2022
    Report Date
    September 21, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    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 MANUFACTURING CHARTS WERE CHECKED, AND NO PRE-EXISTING ANOMALY WAS FOUND ON THE LOT NUMBERS INVOLVED. THIS IS THE FIRST COMPLAINT RECEIVED ON THESE LOT NUMBERS. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING CHARTS WERE CHECKED, AND NO PRE-EXISTING ANOMALY WAS FOUND ON THE LOT NUMBERS INVOLVED. THIS IS THE FIRST COMPLAINT RECEIVED ON THESE LOT NUMBERS. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE ACCESSIBLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT: THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S, WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF PHYSICA KR PROTHESIS DUE TO INSTABILITY IS 0.014%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND 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. NOTE: THIS IS FINAL MDR.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INSTABILITY. SURGEON IMPLANTED A KR KNEE SYSTEM ON (B)(6) 2022, USING THE FOLLOWING COMPONENTS: KR FEMORAL COMPONENT #5 RIGHT (PRODUCT CODE 6511.10.150, LOT NUMBER 2118780, STERILIZATION NUMBER 2100386). PHYSICA TT FIX. TIBIAL TRAY #5 (PRODUCT CODE 6521.14.050, LOT NUMBER 2100067, STERILIZATION NUMBER 2100051). PHYSICA KR TIB. LINER RIGHT #5 (PRODUCT CODE 6531.54.510, LOT NUMBER 2021270, STERILIZATION NUMBER 2100083). AFTERWARDS THE POSTERIOR CRUCIATE LIGAMENT FAILED, AND THE SURGEON CHOSE TO CONVERT THE IMPLANT TO A CEMENTED PS. THE COMPONENTS IMPLANTED DURING THE REVISION SURGERY ARE THE FOLLOWING: PHYSICA PS FEMORAL COMPONENT #5 RIGHT (PRODUCT CODE 6515.09.150, LOT NUMBER 21AS0AD, STERILIZATION NUMBER 2100289). PHYSICA PS TIBIAL LINER #5 (PRODUCT CODE 6535.50.510, LOT NUMBER 22BC064, STERILIZATION NUMBER 2200181). THE PATIENT WAS A FEMALE, 61 YEARS OLD. EVENT HAPPENED IN US.

    Description of Event or Problem · 0

    HOLD FOR RW 3/18 KNEE REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INSTABILITY. SURGEON IMPLANTED A KR KNEE SYSTEM ON (B)(6) 2022, USING THE FOLLOWING COMPONENTS: KR FEMORAL COMPONENT #5 RIGHT (PRODUCT CODE: 6511.10.150, LOT NUMBER: 2118780, STERILIZATION NUMBER: 2100386). PHYSICA TT FIX. TIBIAL TRAY #5 (PRODUCT CODE: 6521.14.050, LOT NUMBER: 2100067, STERILIZATION NUMBER: 2100051). PHYSICA KR TIB. LINER RIGHT #5 (PRODUCT CODE: 6531.54.510, LOT NUMBER: 2021270, STERILIZATION NUMBER: 2100083). AFTERWARDS THE POSTERIOR CRUCIATE LIGAMENT FAILED, AND THE SURGEON CHOSE TO CONVERT THE IMPLANT TO A CEMENTED PS. THE COMPONENTS IMPLANTED DURING THE REVISION SURGERY ARE THE FOLLOWING: PHYSICA PS FEMORAL COMPONENT #5 RIGHT (PRODUCT CODE: 6515.09.150, LOT NUMBER: 21AS0AD, STERILIZATION NUMBER: 2100289). PHYSICA PS TIBIAL LINER #5 (PRODUCT CODE: 6535.50.510, LOT NUMBER: 22BC064, STERILIZATION NUMBER: 2200181). THE PATIENT WAS A FEMALE, 61 YEARS OLD. EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447211 PHYSICA KR TIB. LINER RIGHT #5 PHYSICA KR LINERS (CROSS-LINKED UHMWPE WITH VITAMIN E) - RIGHT #5 - H. 10, MBH LIMACORPORATE S.P.A 6531.54.510 2021270

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention