BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 25-1435 PROMADE SHOULDER

    MDR report key: 25200760 · Received May 18, 2026

    Report

    Report Number
    3008021110-2026-00207
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 18, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390318129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING RECORDS HAS NOT HIGHLIGHT ANY PRE-EXISTING ANOMALY OR NON-CONFORMITY RELEVANT TO THE ISSUE. THE MANUFACTURER WILL SUBMIT FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO GLENOID DISLOCATION. DURING THE REVISION THE WHOLE IMPLANT, CONSISTING BOTH OF LIMA CUSTOM MADE GLENOID COMPONENTS AND DJO COMPONENTS, HAS BEEN EXPLANTED. SPECIFICALLY, PRE-EXISTING FOLLOWING CUSTOM-MADE GLENOID COMPONENTS HAS BEEN EXPLANTED: CMD 25-1435 GLENOID PSI SET 3 (PN 9701.66.246, LOT. 2529206, STER. 2500195); CMD 25-1435 GLENOID IMPLANT (PN 9618.14.1SN, LOT. 2531638, STER. 2500199); CMD 25-1435 GLENOID ANATOMY (PN 9705.AN.24F, LOT. 2529207, STER. 2500195); CORTIC.BONE SCREW D.5 L.22 MM (PN 8432.15.022, LOT. 2113040, STER. 2100238); CORTIC.BONE SCREW D.5 L.24 MM (PN 8432.15.024, LOT. 2505206, STER. 2500072); CORTIC.BONE SCREW D.5 L.34 MM (PN 8432.15.034, LOT. 2430935, STER. 2400249), AND REPLACED WITH DJO COMPONENTS ONLY, INCLUDING ALSO 108 MM HUMERAL STEM, +4 MM LINER AND MONOBLOCK BASEPLATE. SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6)1956. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297988 CMD 25-1435 PROMADE SHOULDER CMD 25-1435 MONOBLOCK GLENOID PHX LIMACORPORATE S.P.A. 9618.14.1SN 2531638 08033390318129

    Patients

    Seq Age Sex Outcome Treatment
    1