BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY

    MDR report key: 18146466 · Received November 16, 2023

    Report

    Report Number
    3008021110-2023-00118
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    October 16, 2023
    Report Date
    March 21, 2024
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICES. THIS IS THE FIRST AND ONLY COMPLAINT INVOLVING THESE LOT #S. THEREFORE, WE CAN CONCLUDE THAT THE PRODUCTS HAVE BEEN CORRECTLY MANUFACTURED BEFORE BEING PLACED ON THE MARKET. WILL FILE FINAL MDR REPORT WHEN INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICES. THIS IS THE FIRST AND ONLY COMPLAINT INVOLVING THESE LOT#S. THEREFORE, WE CAN CONCLUDE THAT THE PRODUCTS HAVE BEEN CORRECTLY MANUFACTURED BEFORE BEING PLACED ON THE MARKET. THE EXPLANTED COMPONENTS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMA CORPORATE FOR FURTHER ANALYSIS. X-RAYS WERE REQUESTED BUT NOT AVAILABLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT. THE CHECK OF THE DHR HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT#S, WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2023: WHERE THE HUMERAL STEM AND HUMERAL BODY WERE REPLACED DUE TO LOOSENING (CAUSE UNKNOWN), CULTURES WERE TAKEN (PENDING CONFIRMATION OF WHETHER THESE WERE NEGATIVE FOR INFECTION). PREVIOUS SURGERY - (B)(6) 2023. PATIENT - FEMALE. DATE OF BIRTH - (B)(6) 2023. EVENT HAPPENED IN USA. PATIENT HISTORY: FAILED THIRD-PARTY CUSTOM GLENOID IMPLANT + BONE EROSION AND DEFORMITY. CURRENT CULTURES CAME BACK NEGATIVE. COMPONENTS EXPLANTED: SMR CEMENTLESS FINNED STEM, COMMERCIAL CODE 1304.15.150 - LOT #2212364 - STER. #2200250. SMR REVERSE HUMERAL BODY, COMMERCIAL CODE 1352.15.010 - LOT #2300313 - STER. #2300050.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2023: WHERE THE HUMERAL STEM AND HUMERAL BODY WERE REPLACED DUE TO LOOSENING (CAUSE UNKNOWN), CULTURES WERE TAKEN (PENDING CONFIRMATION OF WHETHER THESE WERE NEGATIVE FOR INFECTION). PREVIOUS SURGERY: ON (B)(6) 2023, PATIENT: FEMALE, DATE OF BIRTH: ON (B)(6) 1963, EVENT HAPPENED IN: USA. PATIENT HISTORY: FAILED THIRD-PARTY CUSTOM GLENOID IMPLANT + BONE EROSION AND DEFORMITY. CURRENT CULTURES CAME BACK NEGATIVE. COMPONENTS EXPLANTED: SMR CEMENTLESS FINNED STEM, COMMERCIAL CODE: 1304.15.150, LOT#: 2212364, STER. #: 2200250. SMR REVERSE HUMERAL BODY, COMMERCIAL CODE: 1352.15.010, LOT#: 2300313, STER. #: 2300050.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238100 SMR REVERSE HUMERAL BODY SMR REVERSE HUMERAL BODY PHX LIMACORPORATE S.P.A 1352.15.010 2300313

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention