BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 23942282 · Received January 2, 2026

    Report

    Report Number
    3008021110-2025-00163
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    September 15, 2025
    Report Date
    January 2, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390001427
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BASED ON THE FEW INFORMATION RECEIVED, NO PRE-EXISTING ANOMALY WAS DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THIS EVENT. IT SHOULD BE NOTED THAT, BASED ON THE DOCUMENTS SHARED BY THE COMPLAINT SOURCE, IT SEEMS THAT THE COMPONENTS ABOVE MENTIONED ARE NOT THE SAME AS THOSE REPORTED IN THE PREVIOUS SURGERY DOCUMENTATION. IN FACT, LOOKING AT THE DOCUMENTATION OF THE SURGERY PERFORMED ON (B)(6) 2024, THE COMPONENTS REPORTED IN THESE DOCUMENTS (AND IMPLANTED IN THAT OCCASION) ARE THE FOLLOWING: LINER F.METAL BACK GLEN.STANDARD (PART CODE 1377.50.010, LOT NUMBER 20AT5KX, STERILIZATION (B)(4)). SMR HUMERAL HEAD Ø52 MM (PART CODE 1322.09.520, LOT NUMBER 1913126, STERILIZATION (B)(4)). NEUTRAL ADAPTOR TAPER STANDARD (PART CODE 1330.15.270, LOT NUMBER 2220567, STERILIZATION (B)(4)). WE TRIED SEVERAL TIMES TO ASK FOR ADDITIONAL INFORMATION ABOUT WHAT WERE THE CORRECT COMPONENTS INVOLVED IN THIS EVENT, WITHOUT RECEIVING ANY OTHER FEEDBACK. IN ANY CASE, THE MANUFACTURER CHECKED THE CHARTS OF THESE COMPONENTS AS WELL, AND NO PRE-EXISTING ANOMALY WAS FOUND. THEREFORE, CONSIDERING THE VERY FEW INFORMATION AVAILABLE: NO PRE-EXISTING ANOMALY WAS DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS REPORTED IN THIS EVENT. WE DID NOT RECEIVE FURTHER INFORMATION ABOUT THIS EVENT. THE MANUFACTURER HAS NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA CONSIDERING THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR ANATOMIC PROSTHESIS (TOTAL AND HEMI) DUE TO CUFF FAILURE IS AROUND 0.47%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURER 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 WAS PERFORMED ON (B)(6) 2025, DUE TO CUFF FAILURE. THE PATIENT HAD FAILED ROTATOR CUFF, AND THE IMPLANT WAS CONVERTED TO REVERSE CONFIGURATION. ACCORDING TO THE INFORMATION RECEIVED, THE COMPONENTS REMOVED DURING THE HEREBY REPORTED REVISION ARE THE FOLLOWING: SMR HUMERAL HEAD Ø52 MM (PART CODE 1322.09.520, LOT NUMBER 1615749, STERILIZATION UNKNOWN) NEUTRAL ADAPTOR TAPER STANDARD (PART CODE 1330.15.270, LOT NUMBER 2220568, STERILIZATION (B)(4)). SMR TRAUMA HUM. BODY # SHORT (PART CODE 1350.15.030, LOT NUMBER 2220647, STERILIZATION (B)(4)). LINER F.MET.BACK GLEN.STANDARD (PART CODE 1377.50.010, LOT NUMBER 21AT27B, STERILIZATION (B)(4)) PREVIOUS SURGERY PERFORMED ON (B)(6) 2024. THE PATIENT IS A MALE, DATE OF (B)(6) 1964. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4428 SMR SHOULDER HUMERAL HEADS (COCRMO) DIA.52MM HSD LIMACORPORATE S.P.A. 1322.09.520 1615749 08033390001427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention