BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TT MB BASEPLATE

    MDR report key: 21090857 · Received January 7, 2025

    Report

    Report Number
    3008021110-2024-00105
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    November 18, 2024
    Report Date
    December 19, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390089579
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF THE PRODUCTS INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED IN THE ITEMS BELONGING TO THE SAME PRODUCT CODES AND LOT NUMBERS AS THE PRODUCTS REVISED. ACCORDING TO OUR RECORDS: - AT LEAST 43 OUT OF 64 PIECES BELONGING TO LOT NUMBER 23AT252 AND STERILIZATION NUMBER (B)(4) HAVE BEEN IMPLANTED. - AT LEAST 9 OUT OF 11 PIECES BELONGING TO LOT NUMBER 2400526 AND STERILIZATION NUMBER (B)(4) HAVE BEEN IMPLANTED. - AT LEAST 8 OUT OF 12 PIECES BELONGING TO LOT NUMBER 2220794 AND STERILIZATION NUMBER (B)(4) HAVE BEEN IMPLANTED. - AT LEAST 21 OUT OF 56 PIECES BELONGING TO LOT NUMBER 2223558 AND STERILIZATION NUMBER (B)(4) HAVE BEEN IMPLANTED. - AT LEAST 21 OUT OF 30 PIECES BELONGING TO LOT NUMBER 2309329 AND STERILIZATION NUMBER (B)(4) HAVE BEEN IMPLANTED. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. NEITHER REMOVED DEVICES NOR RADIOGRAPHIES OR ADDITIONAL INFORMATION WERE AVAILABLE, THEN NO FURTHER INVESTIGATION COULD BE PERFORMED ON THE EVENT. HOWEVER, ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE EVENT WAS DESCRIBED AS A STAGED REVISION DUE TO A PATIENT INFECTION NOT RELATED TO THE IMPLANT AND THERE WAS NO IMPLANT FAILURE EITHER. THUS, CONSIDERING THAT: - NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF THE PRODUCT CODES INVOLVED IN THE EVENT - ACCORDING TO THE INFORMATION RECEIVED, THE REVISION WAS NOT RELATED TO IMPLANT FAILURE. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA ACCORDING TO THE PMS DATA, THE REVISION RATE OF SMR REVERSE DUE TO INFECTION IS AROUND (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS IS 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

    REVISION SURGERY PERFORMED ON (B)(6)2024, DUE TO INFECTION. THIS WAS A PLANNED REVISION FOR A PATIENT WHO HAD AN INFECTION. THERE WAS NO IMPLANT FAILURE. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 23AT252, STERILIZATION NUMBER (B)(4)). - SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2400526, STERILIZATION NUMBER (B)(4)). - SMR SMALL/STD CONNECTOR +4 (PART CODE 1374.15.324, LOT NUMBER 2220794, STERILIZATION NUMBER (B)(4)). - SMR GLENOID PEG TT S/STD #M (PART CODE 1375.14.662, LOT NUMBER 2223558, STERILIZATION NUMBER (B)(4)). - SMR GLENOID BASEPLATE STANDARD (PART CODE 1375.15.610, LOT NUMBER 2309329, STERILIZATION NUMBER (B)(4)). THE COMPONENTS REMOVED WERE REPLACED WITH THE FOLLOWING NEW COMPONENTS: - SMR RETENTIVE LINER STD (PART CODE 1361.50.810, LOT 20AT149, STERILIZATION NUMBER (B)(4)). - SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2424117, STERILIZATION NUMBER (B)(4)). - SMR SMALL/STD CONNECTOR LAT +2 (PART CODE 1374.15.322, LOT NUMBER 2416523, STERILIZATION NUMBER (B)(4)). - SMR GLENOID PEG TT SMALL/STD #LONG (PART CODE 1375.14.663, LOT NUMBER 2104941, STERILIZATION (B)(4)). - SMR GLENOID BASEPLATE STANDARD (PART CODE 1375.15.610, LOT NUMBER 2120302, LOT NUMBER (B)(4)). DURING THE REVISION SURGERY, IN ADDITION TO THE COMPONENTS LISTED, THE SMR FINNED STEM (CODE 1304.15.017) AND THE SMR REVERSE HUMERAL BODY (CODE 1352.15.010), PREVIOUSLY IMPLANTED, WERE REMOVED AND REPLACED WITH NEW COMPONENTS. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1948. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835349 TT MB BASEPLATE SMR TT METAL BACK BASEPLATE (TI6AL4V) - STANDARD KWT LIMACORPORATE S.P.A. 1375.15.610 2309329 08033390089579

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention