BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID BASEPLATE STANDARD

    MDR report key: 14854151 · Received June 29, 2022

    Report

    Report Number
    3008021110-2022-00057
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    November 1, 2021
    Report Date
    June 29, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS PROCESSED WITH THOSE STERILIZATION #S. THEREFORE, ALL THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE REQUESTED TO THE COMPLAINT SOURCE, BUT THEY WERE 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 CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED BY THE ABOVE-MENTIONED STER. #, 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 0.069%. 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) 2021, DUE TO IMPLANT LOOSENING CAUSED BY INFECTION AND BONE GRAFT RESORPTION. ALL GLENOID COMPONENTS AND THE HUMERAL LINER WERE REMOVED: SMR GLENOID PEG TT S/STD/L #M (PRODUCT CODE 1375.14.662, LOT #1806657 - STER.1800185). SMR GLENOID BASEPLATE STANDARD (PRODUCT CODE 1375.15.610, LOT #1818347 - STER. 1900044). SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2000449 - STER. 2000070). SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2013168 - STER. 2000245) - PRODUCT NOT MARKETED IN THE US. SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #2005614 - STER.2000199) - PRODUCT NOT MARKETED IN THE US. CORTICAL BONE SCREW D.4,5 L.20MM (PRODUCT CODE 8431.15.020, LOT #1917841 - STER. 1900386). CORTICAL BONE SCREW D.4,5 L.50MM (PRODUCT CODE 8431.15.050, LOT #1802058 - STER. 1800068). A HEMI PROSTHESIS WAS PLACED IN. PATIENT IS A MALE. HISTORY OF SHOULDER SURGERIES IS THE FOLLOWING: PRIMARY SURGERY PERFORMED ON (B)(6) 2017, DUE TO CUFF FAILURE/OSTEOARTHRITIS; FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2020, DUE TO IMPLANT LOOSENING. THE EVENT WAS REGISTERED AS COMPLAINT #(B)(4); SECOND REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO INFECTION (HEREBY REPORTED). THIRD REVISION SURGERY TOOK PLACE ON (B)(6) 2022. IT IS THE SECOND-STAGE PLANNED REVISION SURGERY: THE HEMI PROSTHESIS WAS CONVERTED TO REVERSE. THE EVENT IS REGISTERED AS COMPLAINT #(B)(4). EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958003 SMR GLENOID BASEPLATE STANDARD SMR TT METAL BACK BASEPLATE (TI6AL4V) - STANDARD KWS LIMACORPORATE S.P.A. 1375.15.610 1818347

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other