BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 22113640 · Received May 30, 2025

    Report

    Report Number
    3008021110-2025-00063
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 30, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    UDI-DI
    08033390000918
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE FINNED STEMS BELONGING TO THE LOT NUMBER 2114975 AND THE STERILIZATION (B)(4), NO PRE-EXISTING ANOMALY WAS DISCOVERED ON THE 53 ITEMS MANUFACTURED WITH THIS LOT NUMBER. ACCORDING TO THE AVAILABLE RECORDS, AT LEAST (B)(4) ITEMS BELONGING TO THE PRODUCT CODE 1304.15.170 AND LOT NUMBER 2114975 HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT. NEITHER REMOVED DEVICES NOR X-RAYS WERE AVAILABLE FOR ADDITIONAL INVESTIGATION. HOWEVER, ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE PATIENT UNDERWENT A PREVIOUS SURGERY FOR FRACTURE, NO ADDITIONAL DETAILS WERE PROVIDED BY THE COMPLAINT SOURCE ABOUT THE PATIENT'S CONDITION. HENCE, TAKING INTO ACCOUNT THAT: - NO PRE-EXISTING ANOMALIES WERE FOUND BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS BELONGING TO THE LOT NUMBER 2114975 - THE PATIENT UNDERWENT A PREVIOUS SURGERY FOR FRACTURE. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: ACCORDING TO THE RELEVANT PMS DATA, THE REVISION RATE OF SMR CEMENTLESS FINNED STEMS BELONGING TO THE FAMILY CODE (B)(4) DUE TO LOOSENING IS AROUND 0.02%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION 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

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOOSENING. PATIENT UNDERWENT A PREVIOUS REVISION SURGERY WITH THE IMPLANT OF A REVERSE FOR FRACTURE (DATE UNKNOWN). THE FOLLOWING STEM WAS LOOSE AND WAS REMOVED: - SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.170, LOT NUMBER 2114975, STERILIZATION 2100314). THE SURGEON PUT IN A LONG 16X150 REVISION STEM. THE OTHER COMPONENTS PREVIOUSLY IMPLANTED WERE LEFT IN SITU (EXCEPT THE HUMERAL STEM ABOVE MENTIONED, THE REVERSE TRAUMA BODY AND THE LINER): - SMR CONNECTOR SMALL R (PART CODE 1374.15.305, LOT NUMBER 2219451, STERILIZATION (B)(4)). - SMR METAL-BACK GLENOID SMALL R (PART CODE 1375.21.005, LOT NUMBER 2208559, STERILIZATION (B)(4)). - SMR ECCENT. GLENOSPHERE Ø 40MM (PART CODE 1376.09.041, LOT NUMBER 2214738, STERILIZATION (B)(4)). - SMR REVERSE FINNED HUMER. BODY (PART CODE 1352.15.050, LOT NUMBER 2010261, STERILIZATION (B)(4)). - SMR REVERSE LINER +3MM D.40MM (PART CODE 1365.50.815, LOT NUMBER 21AT106, STERILIZATION (B)(4)). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27375 SMR SHOULDER FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.17MM HSD LIMACORPORATE S.P.A. 1304.15.170 2114975 08033390000918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention