BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA KR TIB. LINER RIGHT #5

    MDR report key: 19229776 · Received May 2, 2024

    Report

    Report Number
    3008021110-2024-00036
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 2, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBH
    PMA / PMN Number
    K201084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION BY CHECKING THE MANUFACTURING CHARTS OF LOT NUMBER 2106274, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(6) ITEMS MANUFACTURED WITH THE SAME LOT NUMBER. ACCORDING TO OUR RECORDS, AT LEAST 12 OUT OF 36 TIBIAL LINERS WITH LOT NUMBER 2106274 AND STERILIZATION 2100238 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. NEITHER X-RAYS NOR EXPLANTED COMPONENT WERE AVAILABLE TO BE SHARED WITH THE MANUFACTURER, THEREFORE NO FURTHER INVESTIGATION CAN BE PERFORMED EXCEPT FOR THE CHECK OF THE MANUFACTURING CHARTS. THEREFORE, CONSIDERING THAT: - CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT NUMBER 2106274. - ACCORDING TO THE INFORMATION PROVIDED BY THE COMPLAINT SOURCE, THE SURGEON ATTRIBUTED THE REVISION TO THE LAXITY IN THE TISSUE (SO BASED ON THE SURGEON'S OPINION, THE CAUSE OF THE REVISION WAS RELATED TO PATIENT CONDITION) WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE THE REVISION RATE OF PHYSICA KR TIBIAL LINERS, BELONGING TO THE FAMILY PRODUCT CODES 6531.54.XXX, DUE TO INSTABILITY, TO BE AROUND 0.18%. NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO INSTABILITY. PATIENT HAD INSTABILITY AND NEEDED A REVISION. THE SURGEON ATTRIBUTED THE REVISION TO LAXITY IN THE TISSUE. THE REASON FOR THE PATIENT CONDITION IS UNKNOWN BUT NO IMPLICATION TO FAILURES OF LIMACORPORATE COMPONENT WERE MADE. THE REVISION WAS SUCCESSFUL, AND SURGEON WAS SATISFIED WITH THE STABILITY. THE COMPONENT EXPLANTED IS THE FOLLOWING: PHYSICA KR TIB. LINER RIGHT #5 (COMMERCIAL CODE 6531.54.512, LOT NUMBER 2106274, STERILIZATION 2100238) AND IT WAS REPLACED WITH THE FOLLOWING COMPONENT: PHYSICA KR TIB. LINER RIGHT #5 (COMMERCIAL CODE 6531.54.516, LOT NUMBER 2110643, STERILIZATION 2100318) THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2022. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6),1944. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841739 PHYSICA KR TIB. LINER RIGHT #5 PHYSICA KR LINERS (CROSS-LINKED UHMWPE WITH VITAMIN E) - RIGHT #5 - H. 12 MBH LIMACORPORATE S.P.A. 6531.54.512 2106274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention