BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 21688255 · Received March 25, 2025

    Report

    Report Number
    3008021110-2025-00032
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    January 23, 2025
    Report Date
    March 24, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    UDI-DI
    08033390001427
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE DHRS OF THE INVOLVED LOT#: 1500216, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 60 DEVICES MANUFACTURED WITH THAT LOT#. ACCORDING TO OUR RECORDS, AT LEAST 46 HUMERAL HEADS BELONGING TO LOT#: 1500216 AND STER. 1500066 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT#. DEVICE ANALYSIS: DEVICES INVOLVED WERE NOT RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS EVENT, SPECIFICALLY PRE-OPERATIVE X-RAYS WEREN'T ACCESSIBLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT#: 1500216, THE SUBSCAPULARIS HAS FAILED, AND THAT THE SURVIVORSHIP OF THE PROSTHESIS IS OF ABOUT 10 YEARS, WE CAN STATE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR ANATOMIC PROSTHESIS (TOTAL AND HEMI) DUE TO CUFF FAILURE IS (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 CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC PROSTHESIS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. IT WAS REPORTED THAT THE SUBSCAPULARIS HAS FAILED 10 YEARS POST PRIMARY SURGERY. THE FOLLOWING DEVICES WERE REMOVED AND THE PROSTHESIS WAS CONVERTED TO REVERSE CONFIGURATION: SMR HUMERAL HEAD Ø52 MM (PRODUCT CODE: 1322.09.520, LOT#: 1500216 - STER. 1500066). SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.220, LOT#: 1414382 - STER. 1500033). SMR ECCENTRIC ADAPTOR TAPER STANDARD (PRODUCT CODE: 1330.15.278, LOT#:1502057 - STER. 1500122). SMR TRAUMA HUMERAL BODY# SHORT (PRODUCT CODE: 1350.15.030, LOT#: 1003333 - STER. 1500245). CEMENTED GLENOID 3 PEGS STANDARD (PRODUCT CODE 1379.51.010, LOT#: 14L0379 - STER. 1400294). ACCORDING TO THE RECEIVED INFORMATION, ALL COMPONENTS WERE REMOVED DUE TO THE PRIMARY IMPLANTS BEING IN TOO HIGH. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2015. PATIENT IS A MALE, 67 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114152 SMR SHOULDER HUMERAL HEADS (COCRMO) DIA.52MM KWT LIMACORPORATE S.P.A. HUMERAL HEAD 1500216 08033390001427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention