BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 12474118 · Received September 15, 2021

    Report

    Report Number
    3008021110-2021-00076
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    August 4, 2021
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A CHECK OF THE STERILIZATIONS CHARTS OF THE LOT#S INVOLVED WAS PERFORMED, WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY WAS FOUND ON THE 35 SMR CEMENTLESS FINNED STEMS WITH CODE 130415140 LOT 1916281 STER 1900429. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 63 SMR REVERSE FINNED HUMER. BODIES CODE 135215050 LOT 2003813 STER 2000184. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 106 SMR REVERSE LINERS + 3 MM CODE 136050015 LOT 19AT27X STER 1900383. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 5 SMR GLENOSPHERES Ø36MM SMALL-R CODE 137415105 LOT 1920295 STER 1900428. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 70 SMR UNCEMENT. GLENOIDS #SMALL-R CODE 137520005 LOT 2009738 STER 2000218. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 200 BONE SCREWS Ø6,5 H.25MM CODE 842015020 LOT 2006413 STER 2000209. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 200 BONE SCREWS Ø6,5 H.25MM CODE 842015020 LOT 1921147 STER 2000012. VERY FEW INFORMATION IS AVAILABLE ON THIS CASE AND SPECIFICALLY: NO DETAILS ON THE PATIENT CLINICAL HISTORY (E.G. PREVIOUS CASES OF INFECTION/RELEVANT PATHOLOGIES) WERE PROVIDED; THE COMPLAINT SOURCE COMMUNICATED THAT IT WILL NOT BE POSSIBLE TO SHARE THE X-RAYS WITH LIMACORPORATE; THE INFORMATION ON THE GERM RESPONSIBLE OF THE INFECTION IS NOT AVAILABLE AT THE MOMENT. THEREFORE, NO FURTHER EVALUATION CAN BE PERFORMED. BASED ON THE CHECK OF THE STERILIZATION CHARTS, THE INVOLVED COMPONENTS WERE REGULARLY STERILIZED, NO DEVIATION WAS DETECTED. IN CONCLUSION, LIMACORPORATE CANNOT DETERMINE THE CAUSE OF THE INFECTION, HOWEVER, BASED ON THE ABSENCE OF ANOMALIES DETECTED BY THE CHECK OF THE STERILIZATION CHARTS OF THE COMPONENTS INVOLVED, THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT-RELATED. PMS DATA: BASED ON LIMACORPORATE PMS DATA, WE CAN ESTIMATE A REVISION RATE OF SMR REVERSE SYSTEM DUE TO INFECTION OF 0,06%. NO CORRECTIVE ACTION NEEDED FOR THIS CASE, LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT. NOTE: THIS IS AN INITIAL-FINAL COMBINED MDR.

    Description of Event or Problem · 0

    RIGHT SHOULDER REVISION SURGERY DUE TO INFECTION PERFORMED ON THE (B)(6) 2021. THE PREVIOUS SURGERY TOOK PLACE ON THE (B)(6) 2020, WHEN SMR REVERSE PROSTHESIS WAS IMPLANTED DUE TO FRACTURE OF THE PROXIMAL EPIPHYSIS OF THE RIGHT HUMERUS. DURING THE REVISION ON (B)(6) 2021, THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR CEMENTLESS FINNED STEM CODE 130415140 LOT 1916281 STER 1900429 SMR REVERSE FINNED HUMER. BODY CODE 135215050 LOT 2003813 STER 2000184 SMR REVERSE LINER + 3 MM CODE 136050015 LOT 19AT27X STER 1900383 SMR GLENOSPHERE Ø36MM SMALL-R CODE 137415105 LOT 1920295 STER 1900428 SMR UNCEMENT. GLENOID #SMALL-R CODE 137520005 LOT 2009738 STER 2000218 BONE SCREW Ø6,5 H.25MM CODE 842015020 LOT 2006413 STER 2000209 BONE SCREW Ø6,5 H.25MM CODE 842015020 LOT 1921147 STER 2000012 THE PATIENT IS (B)(6). EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371487 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM HSD LIMACORPORATE SPA 1304.15.140 1916281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention