BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 13010713 · Received December 15, 2021

    Report

    Report Number
    3008021110-2021-00102
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    May 29, 2020
    Report Date
    December 10, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, ALL PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTED ITEMS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. 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 FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE MANUFACTURED COMPONENTS OF THE INVOLVED LOT #S, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR REVERSE IMPLANTS DUE TO INFECTION IS (B)(4). 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 IMPLANT PERFORMED ON (B)(6) 2020, DUE TO INFECTION. IT WAS REPORTED THAT A MINOR SOURCE OF INFECTION WAS PROVEN. THE PATHOGEN RESPONSIBLE FOR THE INFECTION WAS NOT KNOWN. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.200, LOT #1410116 - STER. 2000042). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #1920873 - STER. 2000001). SMR REVERSE LINER STD D.40MM (PRODUCT CODE 1365.50.810, LOT #19AT09K - STER. 1900184). SMR GLENOSPHERE Ø 40MM (PRODUCT CODE 1374.09.121, LOT #1923507 - STER. 2000024). SMR SMALL-R CONNECTOR +4 (PRODUCT CODE 1374.15.314, LOT #1919970 - STER. 1900443). SMR GLENOID PEG TT SMALL-R #M (PRODUCT CODE 1375.14.652, LOT #1922229 - STER. 2000003). SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT #1920029 - STER. 2000003). BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #1922836 - STER. 2000021). BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #1922837 - STER. 2000021). A CEMENTED SPACER WAS IMPLANTED. PATIENT'S HISTORY OF REVISION SURGERIES IS THE FOLLOWING: SMR REVERSE PROSTHESIS IMPLANTED ON (B)(6) 2020; FIRST REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO IMPLANT DISLOCATION. THE EVENT WAS REGISTERED AS COMPLAINT (B)(6) AND REPORTED TO THE FDA BY MFR #3008021110-2021-00100); SECOND REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO IMPLANT DISLOCATION. THE EVENT WAS REGISTERED AS COMPLAINT (B)(4) AND REPORTED TO THE FDA BY MFR #3008021110-2021-00101; THIRD REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO INFECTION (REPORTED ON THIS FORM). IT WAS FURTHER REPORTED THAT THE CEMENT SPACER ALSO DISLOCATED POST (B)(6) SURGERY. A CUSTOMIZED SHOULDER IMPLANT WAS REQUESTED. PATIENT IS A MALE, (B)(6). IT WAS REPORTED HE HAS TYPE 2 DIABETES. HE SUFFERS OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), HYPERCHOLESTEREMIA AND HYPERTENSION. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911845 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM HSD LIMACORPORATE S.P.A. 1304.15.200 1410116

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other