BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA KR LINER

    MDR report key: 16014610 · Received December 20, 2022

    Report

    Report Number
    3008021110-2022-00137
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    August 8, 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

    NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBERS INVOLVED. NO OTHER COMPLAINT REGISTERED ON THE SAME LOT NUMBERS (2024296, 2115018, 2100828). A FINAL REPORT WILL BE SUBMITTED AFTER THE FINAL INVESTIGATION.

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALY WAS DETECTED BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBERS INVOLVED. NO OTHER COMPLAINTS REGISTERED ON THE SAME LOT NUMBERS (2024296, 2115018, 2100828). 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 ISSUES. NOTE: THIS IS FINAL MDR.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO INSTABILITY PERFORMED ON (B)(6) 2022. THE SURGEON ORIGINALLY IMPLANTED A PHYSICA KR SYSTEM ON (B)(6) 2022, COMPOSED BY THE FOLLOWING DEVICES: KR FEMORAL COMPONENT #10 LEFT 6511105A0 LOT 2024296 STER. 2100248. PHYSICA TT FIX. TIBIAL TRAY #8, 652114080 LOT 2115018, STER. 2100271. PHYSICA KR TIB. LINER LEFT #8 653254810 LOT 2100828 STER. 2100140. AFTER POSTERIOR CRUCIATE LIGAMENT FAILURE, HE REVISED TO A CEMENTED PS AND IMPLANTED THE FOLLOWING COMPONENTS: PHYSICA PS FEMORAL COMPONENT 6515095A0 LOT 15AS0CC STER. 2200046. PHYSICA PS TIBIAL LINER 653550810 LOT 21AT2GS STER. 2200007. PATIENT IS MALE, BORN IN 1936. EVENT OCCURRED IN THE USA.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO INSTABILITY WAS PERFORMED ON (B)(6) 2022. THE SURGEON ORIGINALLY IMPLANTED A PHYSICA KR SYSTEM ON (B)(6) 2022, COMPOSED BY THE FOLLOWING DEVICES: - KR FEMORAL COMPONENT #10 LEFT 6511.10.5A0 LOT 2024296 STER. 2100248. - PHYSICA TT FIX. TIBIAL TRAY #8 652.11.4080 LOT 2115018 STER. 2100271. - PHYSICA KR TIB. LINER LEFT #8 6532.54.810 LOT 2100828 STER. 2100140. AFTER POSTERIOR CRUCIATE LIGAMENT FAILURE, HE REVISED TO A CEMENTED PS AND IMPLANTED THE FOLLOWING COMPONENTS: - PHYSICA PS FEMORAL COMPONENT 6515.09.5A0 LOT 15AS0CC STER. 2200046. - PHYSICA PS TIBIAL LINER 6535.508.10 LOT 21AT2GS STER. 2200007. PATIENT IS MALE, BORN IN 1936. EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2885945 PHYSICA KR LINER PHYSICA KR LINERS (CROSS-LINKED UHMWPE WITH VITAMIN E) - LEFT #8 - H. 10, MBH LIMACORPORATE S.P.A 6532.54.810 2100828

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention