BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER SYSTEM

    MDR report key: 24813211 · Received April 8, 2026

    Report

    Report Number
    3008021110-2026-00173
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    February 3, 2026
    Report Date
    April 7, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390102919
    PMA / PMN Number
    K142139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANTED COMPONENTS HAVE NOT BEEN RETURNED TO MANUFACTURER THEREFORE CANNOT BE ANALYSED. REVIEW OF PRODUCTION AND STERILIZATION RECORDS FOR REVISED COMPONENTS HAS BEEN PERFORMED AND DID NOT HIGHLIGHT ANY ANOMALY OR NON-CONFORMITY THAT COULD HAVE CONTRIBUTED TO THE ISSUE. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DUE TO PATIENT COMPLAINT OF PAIN. ORIGINAL SURGERY OCCURRED ON (B)(6) 2025, AND FOLLOWING COMPONENTS WERE IMPLANTED: - SMR GLENOID PEG TT SMALL-R #M (PN 1375.14.652, LOT. 2424760, STER. (B)(4)); - SMR CONNECTOR SMALL R (PN 1374.15.305, LOT. 2126602, STER. (B)(4)); - TT AUGM.360 BASEPLATE #S-R 15° (PN 1375.15.515, LOT. 2100640, STER. (B)(4)); - SMR GLENOSPHERE Ø 40MM (PN 1374.09.121, LOT. 2427991, STER. (B)(4)); - SMR REVERSE LINER STD D.40MM (PN 1365.50.810, LOT. 23AT40K, STER. (B)(4)); - SMR REVERSE FINNED HUMERAL BODY (PN 1352.15.050, LOT. 2023455, STER. (B)(4)); - SMR CEM. REVISION STEM Ø15 MM (PN 1309.15.158, LOT. 1520565, STER. (B)(4)). DURING REVISION SURGERY, HEREBY REPORTED, THE PRE-EXISTING HUMERAL BODY, REVERSE LINER, CONNECTOR AND GLENOSPHERE WERE REMOVED AND REPLACED WITH: - SMR 140° HUMERAL BODY FINNED REVERSE (PN 1352.15.051); - EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001); - SMR REVERSE LINER RETENTIVE STD DIA. 40 MM (PN1365.50.811); - SMR CONNECTOR LAT +2MM + SCREW (PN 1374.15.312); - GLENOSPHERE DIA 40 MM (PN 1374.09.121). SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1951. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76245 SMR SHOULDER SYSTEM REVERSE LINER 40MM STANDARD PHX LIMACORPORATE S.P.A. 1365.50.810 23AT40K 08033390102919

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention