BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMA HUMERAL SYSTEM

    MDR report key: 25067086 · Received May 4, 2026

    Report

    Report Number
    3008021110-2026-00197
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    March 10, 2026
    Report Date
    May 4, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    UDI-DI
    08033390202954
    PMA / PMN Number
    K212800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY PRE-EXISTING ANOMALY OR NON CONFORMITY THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE. FROM FOLLOW-UP COMMUNICATION THE COMPLAINT SOURCE CONFIRMED THAT SURGEON TESTED THE STABILITY OF THE ASSEMBLY DURING ORIGINAL SURGERY, WITH NO ISSUES REPORTED. MOREOVER, THE EXPLANTED COMPONENTS WERE REPORTED TO BE IN GOOD CONDITION WHEN EXPLANTED, THUS EXCLUDING AN EARLY FAILURE OF THE COMPONENTS CAUSING 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 SHOULDER DISLOCATION. ORIGINAL SURGERY WAS PERFORMED ON THE SAME DAY TO IMPLANT A COMBINATION OF FOLLOWING PRIMA HUMERAL COMPONENTS AND DJO ALTIVATE REVERSE GLENOID: PRIMA SHORT STEM PLUS #1 (PN 1357.14.228, LOT 2524131, STERILIZATION (B)(6)) PRIMA REVERSE TRAY #SHORT (PN 1367.15.010, LOT 2518444, STERILIZATION (B)(6)) PRIMA LIMAVIT REVERSE INSERT #SHORT DIA 36MM CORR 0° (PN 1367.54.100, LOT 25AT2RE, STERILIZATION (B)(6)). DJO MODULAR BASEPLATER AND TAPER KIT (PN 508-65-001). DJO RSP GLENOID HEAD AND RETAINING SCREW 2MM LATERAL OFFSET SZ 36MM (PN 508-36-103). PATIENT DISLOCATED AND THE ABOVE MENTIONED PRIMA REVERSE TRAY AND LINER WERE REPLACED: SAME SIZE OF TRAY WAS CHOSEN BY SURGEON, WHILE THE NEW LINER WAS REPLACED WITH A RETENTIVE ONE (PN 1367.54.101). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1957. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148521 PRIMA HUMERAL SYSTEM PRIMA REVERSE INSERT # SHORT DIA.36MM 0° CORR. PHX LIMACORPORATE S.P.A 1367.54.100 25AT2RE 08033390202954

    Patients

    Seq Age Sex Outcome Treatment
    1