BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMC TIBIAL LINER #5 H14 RIGHT

    MDR report key: 15081835 · Received July 22, 2022

    Report

    Report Number
    3008021110-2022-00059
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 24, 2022
    Report Date
    June 24, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HRY
    PMA / PMN Number
    K201084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT# 2016145, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 7 ITEMS MANUFACTURED WITH THE SAME LOT#. NO OTHER COMPLAINTS RECEIVED ON THE SAME LOT#. COMPONENTS WILL BE RETURNED TO LIMACORPORATE FOR FURTHER INVESTIGATION. A FINAL INCIDENT REPORT WILL BE SENT ONCE THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER 2016145, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT NUMBER. NO OTHER COMPLAINTS RECEIVED ON THE SAME LOT NUMBER. COMPONENTS ANALYSIS THE COMPONENTS INVOLVED IN THE COMPLAINT WERE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURED. THEREFORE, IN ORDER TO CONDUCT A MORE THOROUGH INVESTIGATION, ANOTHER LMC TIBIAL LINER #5 H14 RIGHT, WITH THE SAME LOT AND STERILIZATION AS THE ONE COMPLAINED OF, WAS RETRIEVE AND USING A TIBIAL PLATE BELONGING TO A LOT NUMBER CLOSE TO THE COMPONENT IMPLANTED, AN IMPACT TEST WAS PERFORMED. USING THE INSTRUMENT PHYSICA LINERS IMPACTOR (PART CODE 9065.88.160) AS PER SURGICAL TECHNIQUE, THE LINER WAS CORRECTLY PLACED ON THE TIBIAL PLATE. ACCORDING TO THE INFORMATION RECEIVED FROM THE SOURCE OF THE COMPLAINT, THE SURGEON CHECKED FOR DEBRIS DURING THE SURGERY AND FOUND NOTHING. THEREFORE, HE WAS PROBABLY UNABLE TO PROPERLY IMPACT THE POSTERIOR SIDE OF THE COMPONENT, TO ALLOW THE LINER TO ADHERE TO THE TIBIAL PLATE, AND THIS IS THE MOST LIKELY REASON FOR THE EVENT. IN CONCLUSION, STATING THAT: - BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER 2016145, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT NUMBER. - THE MOST LIKELY REASON FOR THE EVENT IS THE INCORRECT IMPACT OF THE LINER ONTO THE TIBIAL PLATE. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA ACCORDING TO OUR PMS DATA, THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ABOUT THIS KIND OF INTRAOPERATIVE ISSUE THAT INVOLVED A LMC TIBIAL LINER. 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 A FINAL MDR.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE EXPERIENCED ON (B)(6) 2022 DURING A KNEE SURGERY: THE TIBIAL LINER (LMC TIBIAL LINER #5 H14 RIGHT - PRODUCT CODE 6536.54.514, LOT 2016145 STER 2100182) DID NOT FIT INTO THE TIBIAL PLATE. ACCORDING TO THE INFO REPORTED, THE LINER KEPT POPPING OUT AFTER BEING PUT INTO PLACE. DUE TO THIS ISSUE, SURGEON REMOVED THE IMPLANT AND CHECK FOR DEBRIS FOUNDING NONE. A NEW SIZE #5 LINER WAS THEN IMPLANTED SUCCESSFULLY. A TOTAL OF 25 MINUTES HAVE BEEN EXPERIENCED DUE TO THIS ISSUE. EVENT HAPPENED IN US.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE EXPERIENCED ON 24TH OF JUNE 2022: THE TIBIAL LINER (LMC TIBIAL LINER #5 H14 RIGHT -PART CODE 6536.54.514, LOT 2016145 STERILIZATION (B)(6)) DID NOT FIT INTO THE TIBIAL PLATE (PHYSICA FIXED TIBIAL PLATE #5, PART CODE 6522.15.050, LOT 2012154, STERILIZATION (B)(6)). ACCORDING TO THE INFO REPORTED, THE LINER KEPT POPPING OUT AFTER BEING PUT INTO PLACE. DUE TO THIS ISSUE, SURGEON REMOVED THE IMPLANT AND CHECK FOR DEBRIS FOUNDING NONE. A NEW LMC TIBIAL LINER #5 H14 RIGHT (WITH SAME LOT NUMBER AS THE PREVIOUS ONE, BUT DIFFERENT STERILIZATION NUMBER) WAS THEN IMPLANTED SUCCESSFULLY. A TOTAL OF 25 MINUTES OF DELAY HAS BEEN EXPERIENCED DUE TO THIS ISSUE. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1967. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116099 LMC TIBIAL LINER #5 H14 RIGHT PHYSICA LMC LINERS (CROSS-LINKED UHMWPE WITH VITAMIN E) - RIGHT #5 - H. 14 HRY LIMACORPORATE S.P.A. 6536.54.514 2016145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization