BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 23630533 · Received November 24, 2025

    Report

    Report Number
    3008021110-2025-00159
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 24, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBF
    UDI-DI
    08033390156974
    PMA / PMN Number
    K201905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW OF MANUFACTURING AND STERILIZATION RECORDS CONFIRMED NO PRE-EXISTING ANOMALY OR NON-CONFORMITY ON INVOLVED BATCHES. REVIEW OF COMPLAINT DATABASE REVEALED NO FURTHER EVENTS ON INVOLVED LOT NUMBERS FROM THE MARKET. REVISION SURGERY HAS BEEN COMPLETED SUCCESSFULLY BY REMOVING THE FINNED HUMERAL BODY AND LINER PREVIOUSLY IMPLANTED, REPLACING THEM WITH A NEW FINNED REVERSE HUMERAL BODY 140° (PART NUMBER: 1352.15.051) AND A REVERSE LINER RETENTIVE +6MM D 40MM (PART NUMBER: 1365.50.821). FROM FOLLOW-UP COMMUNICATION WITH SALES REPRESENTATIVE RESPONSIBLE FOR INVOLVED HOSPITAL IT WAS LEARNED THAT PATIENT NON-COMPLIANCE WAS ASSUMED BASED ON THE FACT THE PATIENT DURING FIRST SURGERY WAS ROCK SOLID AND COULD NOT BE DISLOCATED EVEN UNDER SEDATION, HAS A HISTORY OF ALCOHOLISM AND COULD NOT REMEMBER NEITHER IF HE DID REQUIRED POST OPERATIVE REHABILITATION NOR WHAT HE WAS DOING WHEN HE DISLOCATED THE SHOULDER PROSTHESIS. ACCORDING TO INFORMATION PROVIDED BY MEDICAL TEAM, REPORTED NONCOMPLIANCE MAY HAVE CONTRIBUTED TO REPORTED ISSUE. PATIENT IS 214LBS AND HAS VERY POOR BONE QUALITY, THEREFORE SURGEON IMPLANTED THE 140° FINNED HUMERAL BODY WITH 40MM LINER IN AN OFF-LABEL COMBINATION IN ORDER TO GUARANTEE A MORE STABLE SHOULDER PROSTHESIS. EXPLANTED PARTS WERE NOT RETURNED NOR X-RAYS WERE PROVIDED DESPITE REQUEST, THEREFORE NO FURTHER ROOT CAUSE INVESTIGATION IS POSSIBLE. HENCE, TAKING INTO ACCOUNT THAT: REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT COMPONENTS WERE RELEASED ACCORDING TO SPECIFICATION AND NO DEVIATION WAS DETECTED THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE, NO OTHER SIMILAR EVENT WAS REPORTED ON INVOLVED BATCHES, SURGEON CONFIRMED THAT THE HUMERAL BODY AND LINER WERE PROPERLY PERFORMING WHEN IMPLANTED AND COUPLED DURING ORIGINAL SURGERY, THE MANUFACTURER HAS NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: BASED ON THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR REVERSE HUMERAL BODIES, BELONGING TO THE FAMILY PRODUCT CODES 1352.15.0XX AND 1352.20.XXX DUE TO DISLOCATION IS AROUND 0.03%. 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. NOTE: THIS IS A COMBINED INITIAL FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO DISLOCATION. NON-COMPLIANT PATIENT WITH MENTAL HEALTH ISSUES DISLOCATED HIS SHOULDER BUT DOESN'T KNOW HOW OR WHEN, RESULTING IN POLY LINER SWAP. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH NEW PARTS: FINNED REVERSE HUMERAL BODY 140° (PART NUMBER: 1352.15.051, LOT NUMBER: 2014680, STERILIZATION: 2100020). SMR REVERSE LINER +6MM D 40MM (PART NUMBER: 1365.50.820, LOT NUMBER: 23AT489, STERILIZATION: 2400196). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1947. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2389047 SMR SHOULDER 140° FINNED REVERSE HUMERAL BODY MBF LIMACORPORATE S.P.A. 1352.15.051 2014680 08033390156974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention