BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER SYSTEM

    MDR report key: 24638409 · Received March 19, 2026

    Report

    Report Number
    3008021110-2026-00144
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 19, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390123112
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANTED COMPONENTS HAVE BEEN DISCARDED THEREFORE CANNOT BE RETURNED TO MANUFACTURER FOR ANALYSIS. REVIEW OF MANUFACTURING AND STERILIZATION RECORD DID NOT HIGHLIGHT ANY ANOMALY ON INVOLVED BATCHES. COMPLAINT DATABASE REVIEW FOR INVOLVED LOT AND STERILIZATION NUMBER IDENTIFIED ONLY ONE FURTHER COMPLAINT ON THE SAME BATCH OUT OF TOTAL 56 MANUFACTURED UNITS. REVIEW OF RESULTS OF MICROBIOLOGICAL TESTS FOR CLEAN ROOM CONFIRMED NO DEVIATION IN STERILIZATION PROCESS, THUS EXCLUDING A MANUFACTURING ISSUE. THROUGH FOLLOW-UP COMMUNICATION IT WAS LEARNED THAT PATIENT DID NOT PROVIDE FURTHER INFORMATION REGARDING REHABILITATION AND POST-OP THERAPY AFTER ORIGINAL SURGERY, NEITHER X-RAYS OR LAB RESULTS WERE SHARED. TAKING INTO ACCOUNT THAT: - NO FURTHER INFORMATION IS AVAILABLE REGARDING THE NATURE OF INFECTION SINCE LAB REPORTS HAVE NOT BEEN SHARED; - EXPLANTED COMPONENTS WON'T BE RETURNED; - NO DEVIATION IN MANUFACTURING AND STERILIZATION RECORDS HAS BEEN FOUND, THE MANUFACTURER HAS NO EVIDENCE TO CONSIDER THIS EVENT AS PRODUCT RELATED. ACCORDING TO THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR GLENOSPHERE BELONGING TO THE FAMILY PRODUCT CODES 1374.09.XXX, 1374.15.XXX, 1376.09.XXX, 1376.15.XXX DUE TO INFECTION IS AROUND 0.06%. BASED ON THE INVESTIGATION PERFORMED, NO CORRECTIVE ACTIONS IS REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO INFECTION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 AND FOLLOWING COMPONENTS WERE IMPLANTED: - REVERSE LINER (PN 1365.50.810, LOT. 23AT07N, STER. (B)(4)) - TT AUGMENTED 360 BASEPLATES (PN 1375.15.515, LOT. 2515952, STER. (B)(4)) - 140° HUMERAL BODY (PN 1352.15.051, LOT. 2523962, STER. (B)(4)) - GLENOSPHERE ECCENTRICAL DIA 40MM (PN 1376.09.041, LOT. 2022366, STER. (B)(4)) - CONNECTOR LAT + 2MM + SCREW (PN 1374.15.312, LOT. 2525197, STER. (B)(4)) - FINNED STEM (PN 1304.15.022, LOT. 2327598, STER. (B)(4)) - GLENOID PEG TT (PN 1375.14.652) - BONE SCREW (PN 8420.15.020) - BONE SCREW (PN 8420.15.010) DURING REVISION ALMOST ALL PRE-EXISTING COMPONENTS WERE REMOVED AND NEW RETENTIVE LINER +3MM (PN 1361.50.810), TT AUGMENTED 360 BASEPLATE (PN1375.15.565), 140° HUMERAL BODY (PN 1352.15.051), CONNECTOR LAT 4MM + SCREW (PN1374.15.314), GLENOSPHERE DIA 36 MM (PN 1374.09.111) AND BONE SCREWS (PN 8420.15.010, PN 8420.15.020, 8420.15.030) WERE IMPLANTED. WOUND WAS IRRIGATED AND A TISSUE SAMPLE WAS SENT FOR ANALYSIS. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1958. EVENT OCCURRED IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706639 SMR SHOULDER SYSTEM ECCENTRICAL GLENOSPHERE DIA. 40 MM PHX LIMACORPORATE S.P.A. 1376.09.041 2022366 08033390123112

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention