BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 19772700 · Received July 18, 2024

    Report

    Report Number
    3008021110-2024-00060
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 18, 2024
    Report Date
    November 4, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    UDI-DI
    08033390080613
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND OUT. A FINAL MDR WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE COMPLAINT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND OUT. ACCORDING TO OUR RECORD, AT LEAST (B)(4) ITEMS BELONGING TO THE LOT NUMBER 23AT0V8 AND STERILIZATION NUMBER (B)(4) HAVE BEEN IMPLANTED AND AT LEAST(B)(4) ITEMS BELONGING TO THE LOT NUMBER 2325319 AND STERILIZATION NUMBER (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. NEITHER REMOVED COMPONENTS NOR RADIOGRAPHIES WERE AVAILABLE TO BE SHARED, THEREFORE NO FURTHER INVESTIGATION CAN BE DONE ON THIS EVENT. HOWEVER, CONSIDERING THE DESIGN FEATURES OF THE LINERS, THE RETENTIVE ONE (PART CODE 1361.50.815) ALLOWS THE GLENOSPHERE TO KEEP ITS ORIGINAL POSITION, THANKS TO THE HIGHER EDGES. THEREFORE, THIS KIND OF LINER SHOULD PREVENT THE DISLOCATION OF THE GLENOSPHERE. HENCE, BASED ON THE FEW INFORMATION AVAILABLE: CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY WAS DISCOVERED. ACCORDING TO THE COMMENTS RECEIVED BY THE COMPLAINT SOURCE, THERE WAS NO FAILURE OF THE IMPLANT. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA ACCORDING TO THE RELEVANT PMS DATA, THE REVISION RATE OF SMR REVERSE LINERS, BELONGING TO THE FAMILY PRODUCT CODES 1360.50.XXX, 1361.50.XXX, 1365.50.XXX, DUE TO DISLOCATION IS AROUND 0.07%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION. DURING THE REVISION SURGERY, THE FOLLOWING COMPONENTS WERE REMOVED: - SMR REVERSE LINER STANDARD (PART CODE 1360.50.810, LOT NUMBER 23AT0V8, STERILIZATION NUMBER 2300114), - SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2325319, STERILIZATION NUMBER 2300244), - SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2327395, STERILIZATION NUMBER 2300268), THE COMPONENTS ABOVE MENTIONED WERE REPLACED BY THE FOLLOWING NEW COMPONENTS: - SMR REVERSE LINER RETENTIVE (PART CODE 1361.50.815, LOT NUMBER 21AT0F5, STERILIZATION NUMBER 2100357), - SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2218959, STERILIZATION NUMBER 2200245), - SMR CONNECTOR+SCREW SMALL R (PART CODE 1374.15.305, LOT NUMBER 2411586, STERILIZATION NUMBER 2400091). THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. DURING THIS SURGERY, THE SMR REVERSE HUMERAL BODY SHORT (PART CODE 1352.15.005, LOT NUMBER 2202133, STERILIZATION NUMBER 2200062) WAS ALSO IMPLANTED (AND NOT REMOVED DURING THE REVISION SURGERY). THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1956. THE EVENT HAPPENED IN THE UNITED STATES.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION. DURING THE REVISION SURGERY, THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE LINER STANDARD (PART CODE 1360.50.810, LOT NUMBER 23AT0V8, STERILIZATION NUMBER (B)(4). SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2325319, STERILIZATION NUMBER (B)(4). SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2327395, STERILIZATION NUMBER (B)(4). THE COMPONENTS ABOVE MENTIONED WERE REPLACED BY THE FOLLOWING NEW COMPONENTS: SMR REVERSE LINER RETENTIVE (PART CODE 1361.50.815, LOT NUMBER 21AT0F5, STERILIZATION NUMBER (B)(4). SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2218959, STERILIZATION NUMBER (B)(4). SMR CONNECTOR+SCREW SMALL R (PART CODE 1374.15.305, LOT NUMBER 2411586, STERILIZATION NUMBER (B)(4). THE PREVIOUS SURGERY TOOK PLACE ON (B)(6)2024. DURING THIS SURGERY, THE SMR REVERSE HUMERAL BODY SHORT (PART CODE 1352.15.005, LOT NUMBER 2202133, STERILIZATION NUMBER (B)(4). WAS ALSO IMPLANTED (AND NOT REMOVED DURING THE REVISION SURGERY). THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6)1956. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551451 SMR SHOULDER REVERSE LINERS 36MM (UHMWPE) STANDARD KWS LIMACORPORATE S.P.A. 1360.50.810 23AT0V8 08033390080613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention