BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE LINER +3MM D.40MM

    MDR report key: 16442525 · Received February 27, 2023

    Report

    Report Number
    3008021110-2023-00017
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    January 30, 2023
    Report Date
    June 9, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    PMA / PMN Number
    K142139
    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 #21AT2FW NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THIS LOT #. NO OTHER COMPLAINTS REPORTED ON THE SAME LOT NUMBER. 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. X-RAY ANALYSIS 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 DUE TO INFECTION IS P ACNE. 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 0.075%. 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 FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2023 DUE TO INFECTION (P.ACNE). DURING THE REVISION SURGERY, THE SMR REVERSE LINER +3MM D.40MM - PRODUCT CODE 1365.50.815, LOT 21AT2FW, STER. 2200049 ORIGINALLY IMPLANTED ON (B)(6) 2022, WAS REPLACED WITH A LARGER LINER + 6MM. DEBRIDEMENT OF THE INFECTION SITE TO HOPEFULLY MITIGATE THE INFECTION WAS ALSO PERFORMED. PATIENT - MALE. DATE OF BIRTH - (B)(6) 1951 EVENT HAPPENED IN US.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2023 DUE TO INFECTION (P.ACNE). DURING THE REVISION SURGERY, THE SMR REVERSE LINER +3MM D.40MM - PRODUCT CODE 1365.50.815, LOT 21AT2FW, STER. 2200049 ORIGINALLY IMPLANTED ON (B)(6), 2022, WAS REPLACED WITH A LARGER LINER + 6MM. DEBRIDEMENT OF THE INFECTION SITE TO HOPEFULLY MITIGATE THE INFECTION WAS ALSO PERFORMED. EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799397 SMR REVERSE LINER +3MM D.40MM SMR REVERSE LINER +3MM D.40MM PHX LIMACORPORATE S.P.A 1365.50.815 21AT2FW

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention