BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SYSTEM

    MDR report key: 22370033 · Received July 1, 2025

    Report

    Report Number
    3008021110-2025-00082
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    April 16, 2025
    Report Date
    July 1, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    UDI-DI
    08033390272551
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED WITH LOT NUMBER: 2430835 AND LOT NUMBER: 2434844, NO PRE-EXISTING ANOMALIES WERE FOUND IN THE PIECES MANUFACTURED WITH THESE LOT NUMBERS. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ABOUT THE INVOLVED LOT NUMBERS. THE EXPLANTED DEVICES WERE NOT RETURNED FOR FURTHER INSPECTION TO LIMACOPORATE. THE PRE-OPERATIVE AND POST-OPERATIVE X-RAYS OF BOTH SURGERIES WERE PROVIDED BY THE COMPLAINT SOURCE. THE AVAILABLE INFORMATION AND THE X-RAYS WERE EVALUATED BY A MEDICAL CONSULTANT AND HEREBY HIS COMMENT ON THE EVENT: "AFTER FIRST IMPLANTATION THE RADIOGRAPHS SHOW A MALPOSITIONED GLENOID COMPONENT, LOOKS LIKE AXIOMA WITH BONEGRAFT, VERY DIVERGENT SCREWS. THE SUBSEQUENT IMAGES SHOW UPWARD MIGRATION AND LOOSENING OF THE METALBACK. IT STARTED WITH A RATHER NORMAL BONE DEFORMITY BEFORE THAT. OVERALL, IT LOOKS SUSPICIOUS FOR SURGICAL ERRORS, SUCH AS IMPROPER BASEPLATE FIXATION TO ME. THE SUBSEQUENT REVISION WITH EXPLANTATION OF GLENOID PARTS AND THE METAPHYSEAL PART TO PREPARE FOR PROMADE CUSTOM-MADE GLENOID, IS UNREMARKABLE. THE RADIOGRAPH POST PROMADE IMPLANTATION SHOWS A FRACTURES GREATER TUBEROSITY. THIS IS EITHER DUE TO SURGICAL ERROR DURING REVISION OR TRAUMA IMMEDIATELY POSTOP., WHICH WE DON'T KNOW. THIS THAN IS A REASON FOR THE FURTHER DESCRIBED DISLOCATIONS, BECAUSE THE DISLOCATED GREATER TUBEROSITY IS A LEVER TO THE POSTERIOR GLENOID DURING EXTERNAL ROTATION AND ABDUCTION. SO AGAIN, SUSPICION FOR SURGICAL ERROR. THERE IS NO SIGN FOR IMPLANT-RELATED FAILURE, BUT EITHER SURGICAL MISTAKE OR FATEFUL COURSE OF EVENTS." IN CONCLUSION, CONSIDERING THAT: THE CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON LOT NUMBERS: ACCORDING TO THE MEDICAL CONSULTANT "THE RADIOGRAPH POST PROMADE IMPLANTATION SHOWS A FRACTURES GREATER TUBEROSITY. THIS IS EITHER DUE TO SURGICAL ERROR DURING REVISION OR TRAUMA IMMEDIATELY POSTOP., WHICH WE DON'T KNOW". WE MAY STATE THAT THE EVENT WAS NOT PRODUCT RELATED, RATHER A SURGICAL FACTOR OR PATIENT'S CONDITION COULD HAVE CONTRIBUTED TO THE DISLOCATION. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE DUE TO DISLOCATION IS NEARLY (B)(4). 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 AN INITIAL - FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION OF AN SMR REVERSE PRODUCTS IN COMBINATION WITH PROMADE COMPONENTS (CMD 24-1350). THE INITIAL SURGERY HAD TAKEN PLACE ON (B)(6) 2025. A FEW WEEKS LATER, THE PATIENT RETURNED TO THE HOSPITAL, AND X-RAYS CONFIRMED THE DISLOCATION. REMOVED THE EXPLANTS BELOW: SMR REVERSE HUMERAL BODY SHORT (CODE 1352.15.005, LOT N. 2430835, STER. N. (B)(4) - SOLD IN US SMR REVERSE HP GLENOSPH. 40 MM (CODE 1374.50.400, LOT N. 2434844, STER. N. (B)(4) - NOT SOLD IN US. PATIENT: FEMALE, DOB: (B)(6) 1964. THE SAME PATIENT UNDERWENT A PREVIOUS REVISION SURGERY DUE TO DISLOCATION. FOR THIS EVENT COMPLAINT WITH REFERENCE (B)(4) HAS BEEN REGISTERED (MDR REPORT NUMBER: 3008021110-2025-00083). EVENT HAPPENED IN UNITED KINGDOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430844 SMR SYSTEM SMR SYSTEM - HUMERAL BODY REVERSE SHORT KWS LIMACORPORATE S.P.A. 1352.15.005 2430835 08033390272551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention