BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID BASEPLATE SMALL-R

    MDR report key: 15649313 · Received October 21, 2022

    Report

    Report Number
    3008021110-2022-00101
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 29, 2022
    Report Date
    January 20, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K133349
    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 LOTS #1811413 AND #2003258, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THOSE LOT #S. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOTS #1811413 AND #2003258, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THOSE LOT #S. FURTHER CHECKING THE STERILIZATION CHARTS OF ALL INVOLVED DEVICES, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS. THEREFORE, THE PRODUCTS PLACED ON THE MARKET WITH THOSE 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 THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: · PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; · PATHOGEN RESPONSIBLE FOR THE INFECTION; · CLINICAL DATA FOR THE PATIENT. 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 MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOTS #1811413 AND #2003258; · IT WAS CONFIRMED THAT INFECTION WAS PRESENT; · CHECK OF THE STERILIZATION CHARTS OF ALL INVOLVED DEVICES HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS; 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 LOOSENING IS 0.09%. 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) 2022, DUE TO LOOSENING OF THE BASEPLATE. IT WAS REPORTED THAT THE EVENT COULD HAVE BEEN POSSIBLY CAUSED BY INFECTION, AND SWABS AND SAMPLES WERE TAKEN. ACCORDING TO THE RECEIVED INFORMATION, GLENOID COMPONENTS CAME OUT AS ONE CONSTRUCT AND WERE ALL REMOVED: SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #1811413 - STER. 1800266). SMR GLENOID PEG TT SMALL-R #M (PRODUCT CODE 1375.14.652, LOT #2003258 - STER. 2000130). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2005409 - STER. 2000172). SMR ECCENTRIC GLENOSPHERE Ø 36MM (PRODUCT CODE 1376.09.031, LOT #2000442 - STER. 2000028). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2006423 - STER. 2000209). BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2005315 - STER. 2000181). THE PROSTHESIS WAS CONVERTED TO CTA HEMI. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS A FEMALE, 69 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO LOOSENING OF THE BASEPLATE. IT WAS REPORTED THAT THE EVENT COULD HAVE BEEN POSSIBLY CAUSED BY INFECTION, THUS SWABS AND SAMPLES WERE TAKEN. IT WAS THEN REPORTED THAT INFECTION WAS PRESENT (PATHOGEN NOT KNOWN). ACCORDING TO THE RECEIVED INFORMATION, GLENOID COMPONENTS CAME OUT AS ONE CONSTRUCT AND WERE ALL REMOVED: · SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #1811413 - STER. 1800266). · SMR GLENOID PEG TT SMALL-R #M (PRODUCT CODE 1375.14.652, LOT #2003258 - STER. 2000130). · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2005409 - STER. 2000172). · SMR ECCENTRIC GLENOSPHERE Ø 36MM (PRODUCT CODE 1376.09.031, LOT #2000442 - STER. 2000028). · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2006423 - STER. 2000209). · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #2005315 - STER. 2000181). THE PROSTHESIS WAS CONVERTED TO CTA HEMI. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2020. PATIENT IS A FEMALE, 69 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557869 SMR GLENOID BASEPLATE SMALL-R SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R KWS LIMACORPORATE S.P.A. 1375.15.605 1811413

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention