BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 18493479 · Received January 11, 2024

    Report

    Report Number
    3008021110-2024-00002
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    December 22, 2023
    Report Date
    January 4, 2024
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICES. THEREFORE, THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE AVAILABLE. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT; · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S. · IT WAS REPORTED PATIENT REQUIRED REVISION FROM INFECTION THAT WAS REPORTED AS NOT IMPLANT 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 0.080%. 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 OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6), 2023, DUE TO INFECTION. IT WAS REPORTED PATIENT REQUIRED REVISION FROM INFECTION THAT WAS REPORTED AS NOT IMPLANT RELATED. THE SURGERY WAS SUCCESSFUL. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A MALE. DATE OF BIRTH - (B)(6) 1965 EVENT HAPPENED IN U.S.A COMPONENTS EXPLANTED; SMR REVERSE HUMERAL BODY SHORT, COMMERCIAL CODE 1352.15.005 - LOT #2202509 - STER. #2200076 SMR REVERSE LINER +6MM D.40MM' COMMERCIAL CODE 1365.50.820 - LOT #21AT2FX - STER. #2200027 SMR GLENOSPHERE Ø 40MM' COMMERCIAL CODE 1374.09.121 - LOT #2205144 - STER. #2200103 SMR SMALL-R CONNECTOR +2', COMMERCIAL CODE 1374.15.312 - LOT #2213671 - STER. # 2200167

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644318 SMR REVERSE HUMERAL BODY SHORT SMR REVERSE HUMERAL BODY SHORT PHX LIMACORPORATE S.P.A 1352.15.005 2202509

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention