BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 25275483 · Received May 26, 2026

    Report

    Report Number
    3008021110-2026-00219
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWT
    UDI-DI
    08033390068727
    PMA / PMN Number
    K161476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING RECORDS DID NOT HIGLIGHT ANY PRE-EXISTING NON-CONFORMITY. FROM FOLLOW-UP COMMUNICATION WITH COMPLAINT SOURCE IT WAS CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE AND NO X-RAYS WILL BE PROVIDED. COMPLAINT DATABASE REVIEW DID NOT HIGHLIGHT ANY FURTHER COMPLAINT FOR ALL BATCHES OF EXPLANTED COMPONENTS, THUS EXCLUDING A SYSTEMATIC QUALITY ISSUE. TAKING INTO ACCOUNT THAT: - DHR REVIEW DID NOT HIGHLIGHT ANY ANOMALY, - NO FURTHER EVENTS HAVE BEEN REPORTED FOR INVOLVED LOTS, - CONVERSION OF THE ASSEMBLY FROM AN ANATOMIC TO A REVERSE CONFIGURATION AFTER ABOUT 5 YEARS FROM ORIGINAL IMPLANT SUGGESTS A POSSIBLE PROGRESSION OF ROTATOR CUFF DEFICIENCY (EVEN IF NOT CONFIRMED BY COMPLAINT SOURCE), THE MANUFACTURER HAS NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. CONVERSION FROM ANATOMIC TO REVERSE CONFIGURATION IS FORESEEN IN CASE OF PROGRESSION OF PATIENT ROTATOR CUFF INSUFFICIENCY PATHOLOGY AND THE SYSTEM IS INDEED DESIGNED AS MODULAR PLATFORM TO ALLOW REVISION WITH A LESS INVASIVE AND EASIER SURGICAL PROCEDURE. BASED ON THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR HUMERAL HEADS, BELONGING TO THE FAMILY PRODUCT CODES 1322.09.XXX IS AROUND (B)(4). ACCORDING TO THE INVESTIGATION CARRIED OUT, NO CORRECTIVE ACTION IS NEEDED FOR THIS EVENT. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET IN ORDER TO DETECT ANY SIMILAR EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO UNKNOWN REASON. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021 WHEN FOLLOWING ANATOMIC CONFIGURATION OF SMR SYSTEM WAS IMPLANTED: - FINNED STEM DIA17MM L80 (PN 1304.15.270). - FINNED HUMERAL BODY (PN 1350.15.110, LOT 2110797, STERILIZATION (B)(4)). - ADAPTOR TAPER ECCENTRICAL 2MM (PN 1330.15.272, LOT 2108248, STERILIZATION (B)(4)). - HUMERAL HEAD DIA50 H16 (PN 1322.09.501, LOT 2010990, STERILIZATION (B)(4)). - METAL BACK GLENOID STD (PN 1375.21.010). - LINER FOR METAL BACK STD (PN 1377.50.010, LOT 20AT5KW, STERILIZATION (B)(4)). DURING REVISION THE PRE-EXISTING FINNED HUMERLA BODY, ADAPTOR TAPER, HUMERAL HEAD AND LINER FOR METAL BACK WERE REMOVED AND THE CONSTRUCT WAS CONVERTED TO A REVERSE CONFIGURATION IMPLANTING: - REVERSE HUMERAL BODY (PN 1352.15.010). - REVERSE LINER +6MM (PN 1360.50.820). - CONNECTOR + SCREW SMALL STD (PN 1374.15.310). - GLENOSPHERE ECCENTRICAL DIA36 (PN 1376.09.031). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1958. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26814 SMR SHOULDER HUMERAL HEADS (COCRMO) - DIA.50MM H.16 KWT LIMACORPORATE S.P.A 1322.09.501 2010990 08033390068727

    Patients

    Seq Age Sex Outcome Treatment
    1