BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 10885224 · Received November 23, 2020

    Report

    Report Number
    3008021110-2020-00101
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    November 6, 2020
    Report Date
    May 12, 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 PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO ADDITIONAL DETAILS WERE AVAILABLE ON THE POST-OPERATIVE ISSUE RATHER THAN A PICTURE RECEIVED ABOUT THE EXPLANTED COMPONENTS. SPECIFICALLY, THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: · PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; · GERM RESPONSIBLE FOR THE INFECTION. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, STATING THAT THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS DUE TO INFECTION IS 0,06%. 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 OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2020 DUE TO A GLENOHUMERAL JOINT INFECTION. ALL THE COMPONENTS WERE EXPLANTED: · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.160, LOT# 1910032 - STER. 1900327); · SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT# 1918570 - STER. 1900438) - PRODUCT NOT MARKETED IN THE US; · SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT# 1910151 - STER. 1900298) - PRODUCT NOT MARKETED IN THE US; · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 1916957 - STER. 1900376); · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT# 1921100 - STER. 1900441) - PRODUCT NOT MARKETED IN THE US; · SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT# 1918670 - STER. 1900444) - PRODUCT NOT MARKETED IN THE US; · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT# 1919946 - STER. 1900457); · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT# 1917056 - STER. 1900378). A CEMENT SPACER WAS IMPLANTED. PREVIOUS REVISION SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS A MALE. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT THE FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO A GLENOHUMERAL JOINT INFECTION. ALL THE COMPONENTS WERE EXPLANTED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.160, LOT# 1910032 - STER. 1900327); SMR REVERSE HUMERAL BODY (PRODUCT CODE: 1352.20.010, LOT# 1918570 - STER. 1900438) PRODUCT NOT MARKETED IN THE US. SMR REVERSE HP LINER SHORT (PRODUCT CODE: 1365.09.010, LOT# 1910151 - STER. 1900298) PRODUCT NOT MARKETED IN THE US. SMR CONNECTOR SMALL R (PRODUCT CODE: 1374.15.305, LOT# 1916957 - STER. 1900376) SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE: 1374.50.400, LOT# 1921100 - STER. 1900441) PRODUCT NOT MARKETED IN THE US. SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE: 1375.20.005, LOT# 1918670 - STER. 1900444) - PRODUCT NOT MARKETED IN THE US. BONE SCREW ¿6,5 H.25MM (PRODUCT CODE: 8420.15.020, LOT# 1919946 - STER. 1900457); BONE SCREW ¿6,5 H.35MM (PRODUCT CODE: 8420.15.040, LOT# 1917056 - STER. 1900378). A CEMENT SPACER WAS IMPLANTED. PREVIOUS REVISION SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS A MALE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348647 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM HSD LIMACORPORATE S.P.A. 1304.15.160 1910032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention