BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 23693253 · Received December 2, 2025

    Report

    Report Number
    3008021110-2025-00153
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 2, 2025
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    HSD
    UDI-DI
    08033390002035
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. REVIEW OF MANUFACTURING AND STERILIZATION RECORDS DID NOT IDENTIFY ANY PRE-EXISTING ANOMALY OR NONCONFORMITY THAT MAY HAVE CONTRIBUTED TO REPORTED ISSUE. COMPLAINT DATABASE REVIEW DID NOT HIGHLIGHT ANY FURTHER SIMILAR ISSUES ON INVOLVED BATCHES FROM THE MARKET. FROM FOLLOW-UP COMMUNICATION WITH SALES REPRESENTATIVE IT WAS LEARNED THAT SURGEON OPTED FOR A REVERSE CONFIGURATION BECAUSE IT WAS DEEMED BETTER FOR THE PATIENT AND THE GLENOSPHERE THAT WAS IMPLANTED FOR REVERSE CONFIGURATION IN REVISION WAS FROM A DIFFERENT MANUFACTURER (TORNIER). NO FURTHER INFORMATION IS AVAILABLE REGARDING THE NATURE OF INFECTION SINCE IT IS NOT KNOWN IF CULTURES HAVE BEEN PERFORMED AND IN CASE WHICH IS THEIR OUTCOME, NOR THE EXPLANTED COMPONENTS WILL BE RETURNED TO MANUFACTURER, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE TO DETERMINE ROOT CAUSE OF THIS EVENT. BASED ON ALL GATHERED INFORMATION AND CONSIDERING THAT NO DEVIATION IN MANUFACTURING AND STERILIZATION RECORDS HAS BEEN FOUND, THE MANUFACTURER HAS NO EVIDENCE TO CONSIDER THIS EVENT AS PRODUCT RELATED. PMS DATA ACCORDING TO THE AVAILABLE PMS DATA, THE REVISION RATE OF SMR HUMERAL BODIES BELONGING TO THE FAMILY PRODUCT CODES 1350.15.XXX DUE TO INFECTION IS AROUND 0.03%. BASED ON THE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, 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 PERFORMED ON (B)(6) 2025 DUE TO PAIN AND SUSPECTED INFECTION. PATIENT WAS EXPERIENCING PAIN, SURGEON SUSPECTED INFECTION. FOLLOWING COMPONENTS WERE REMOVED DURING SURGERY: - SMR HUMERAL HEAD D.46 H.15MM (PART NUMBER 1321.09.461, LOT NUMBER 2200510, STERILIZATION 2200067), - SMR ECC.ADAPTOR TAPER STANDARD (PART NUMBER 1330.15.274, LOT NUMBER 2013120, STERILIZATION 2000264), - SMR FINNED HUMERAL BODY (PART NUMBER 1350.15.110, LOT NUMBER 2213920, STERILIZATION 2200221) - CEMENTED GLENOID 3 PEGS SMALL (PART NUMBER 1379.50.020, LOT NUMBER 20AT5EG, STERILIZATION 2200049). REVERSE CONFIGURATION (REVERSE HUMERAL BODY PART NUMBER 1352.15.005, EXTENSION FOR HUMERAL REVERSE BODY PART NUMBER 1352.15.001, RETENTIVE LINER PART NUMBER 1361.50.815) WAS IMPLANTED DURING REVISION. PREVIOUS SURGERY DATE IS UNKNOWN. PATIENT IS MALE, DATE OF BIRTH (B)(6)1955. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959252 SMR SHOULDER FINNED HUMERAL BODIES WITH LOCKING SCREW HSD LIMACORPORATE S.P.A 1350.15.110 2213920 08033390002035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention