BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 17386934 · Received July 25, 2023

    Report

    Report Number
    3008021110-2023-00097
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 20, 2023
    Report Date
    July 24, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS FOR STERILIZATION OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALIES WERE FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT # FOR STERILIZATION. THE ITEM INVOLVED WAS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE INFECTION DESCRIPTION. PREOPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THE FACTS: THE CHECK OF THE STERILIZATION ON MANUFACTURING CHART HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S. THE AGENT CONFIRMED THAT THE IMPLANT WAS NOT THE CAUSE OF THE INFECTION, AND THAT THE SURGERY WAS A SUCCESS. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS ANALYSIS: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROTHESIS IS 0.078% FOR INFECTION. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUES. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    ON (B)(6) 2023, SHOULDER REVISION SURGERY WAS PERFORMED. PATIENT BECAME INFECTED AND WAS REVISED. THE AGENT CONFIRMED THAT THE IMPLANT WAS NOT THE CAUSE OF THE INFECTION, AND THAT THE SURGERY WAS A SUCCESS. PREVIOUS SURGERY ON (B)(6) 2022; PATIENT - MALE; DATE OF BIRTH - (B)(6) 1942. ITEMS EXPLANTED: SMR REVERSE HUMERAL BODY SHORT, COMMERCIAL CODE 135215005 - LOT #2119705 - STER. #2100322; SMR REVERSE LINER + 3 MM, COMMERCIAL CODE 136050815 - LOT #19AT3K2 - STER. #2000278.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271504 SMR REVERSE HUMERAL BODY SHORT SMR REVERSE HUMERAL BODY SHORT PHX LIMACORPORATE S.P.A 1352.15.005 2119705

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention