BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY

    MDR report key: 16917492 · Received May 12, 2023

    Report

    Report Number
    3008021110-2023-00043
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    March 7, 2023
    Report Date
    May 11, 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

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOTS, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, WE CAN ENSURE THAT ALL THE PRODUCTS PLACED ON THE MARKET WITH THESE LOTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE REQUESTED TO THE COMPLAINT SOURCE, HOWEVER THEY WERE NOT AVAILABLE. BASED ON THE FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. CONSIDERING THAT: ·CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH THE INVOLVED STERILIZATION LOT #S. ·ACCORDING TO THE SURGEON THE INFECTION WAS NOT PRODUCT RELATED. WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION IS 0.076%. 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 ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, DUE TO INFECTION. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINT SOURCE, THE CAUSES OF THE INFECTION ARE NOT KNOWN, HOWEVER IT WAS REPORTED THAT ACCORDING TO THE SURGEON THE INFECTION WAS NOT PRODUCT RELATED. COMPONENTS EXPLANTED. SMR REVERSE HUMERAL BODY, COMMERCIAL CODE #1352.15.010 - LOT #2024178 - STER. #2100045. SMR REVERSE LINER +3MM D.40MM - COMMERCIAL CODE #1365.50.815 - LOT #20AT4V5 - STER. #2000405 . SMR GLENOSPHERE Ø 40MM - COMMERCIAL CODE #1374.09.121 - LOT #2103800 - STER. #2100101. SMR CONNECTOR SMALL R - COMMERCIAL CODE #1374.15.305 - LOT #2104966 - STER. #2100110. INITIAL SURGERY - (B)(6) 2021. PATIENT - MALE. BIRTH DATE - (B)(6) 1960. EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475665 SMR REVERSE HUMERAL BODY SMR REVERSE HUMERAL BODY PHX LIMACORPORATE S.P.A 1352.15.010 2024178

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention