BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM

    MDR report key: 10885231 · Received November 23, 2020

    Report

    Report Number
    3008021110-2020-00098
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    October 12, 2020
    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

    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. THE FOLLOWING INFORMATION WERE ASKED TO THE COMPLAINT SOURCE, BUT WERE NOT AVAILABLE: - PATIENT'S INFORMATION/RELEVANT CLINICAL CONDITIONS. - PRE-OPERATIVE X-RAYS OF THE REVISION SURGERY. - CAUSE OF THE INFECTION, GERM RESPONSIBLE. - CAUSE OF THE PREVIOUS SURGERY. - EXPLANTS AVAILABILITY TO BE RETURNED. WITHOUT THIS INFORMATION, NO DEEPER ANALYSIS CAN BE PERFORMED ON THE CAUSE OF THE INFECTION. HOWEVER: - BASED ON THE CHECK OF THE STERILIZATION CHARTS, THE COMPONENTS INVOLVED WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. - THE COMPLAINT SOURCE STATED THAT THE INFECTION WAS NOT DUE TO PRODUCTS THEMSELVES. IN CONCLUSION, THE CAUSE OF INFECTION CANNOT BE DETERMINED, BUT IT DOES NOT SEEM TO BE PRODUCT-RELATED. PMS DATA: BASED ON LIMACORPORATE PMS DATA, WE ESTIMATE A REVISION RATE OF THE SMR REVERSE SYSTEM DUE TO INFECTION OF (B)(4). NO CORRECTIVE ACTION IS NEED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6), 2020 DUE TO INFECTION. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.160, LOT# 1702881 - STER. 1700147). · SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.15.010, LOT# 1921256 - STER. 2000016). · SMR REVERSE LINER +6 MM (PRODUCT CODE 1360.50.820, LOT# 19AT280 - STER. 1900420). · SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT# 1916955 - STER. 1900376). · SMR SMALL-R CONNECTOR +2 (PRODUCT CODE 1374.15.312, LOT# 1919129 - STER. 1900452). · SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT# 1510923 - STER. 1500306). · SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT# 1913111 - STER. 1900330). · BONE SCREW Ø6,5 H.40MM (PRODUCT CODE 8420.15.050, LOT# 1611920 - STER. 1600227). · BONE SCREW Ø6,5 H.40MM (PRODUCT CODE 8420.15.050, LOT# 1514608 - STER. 1500356). DURING THE REVISION SURGERY ALL THE IMPLANTS IN SITU WERE REMOVED AND NO PROSTHESIS WAS IMPLANTED. THE COMPLAINT SOURCE REPORTED THAT THE INFECTION WAS NOT CAUSED BY THE IMPLANTS. ACCORDING TO THE INFORMATION RECEIVED, THE PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2020 AND WAS A REVISION SURGERY AS WELL (REGISTERED AS COMPLAINT NUMBER (B)(4) AND REPORTED TO FDA AS MFR REPORT# 3008021110-2020-00099). THE CAUSE OF THE PREVIOUS REVISION IS NOT KNOWN. THE PRIMARY SURGERY TOOK PLACE ON (B)(6), 2019. THE STEM (PRODUCT CODE 1304.15.160, LOT# 1702881 - STER. 1700147) HAD BEEN IMPLANTED DURING THE SURGERY ON (B)(6) 2019, WHILE THE OTHER COMPONENTS DURING THE REVISION SURGERY ON (B)(6), 2020. EVENT HAPPENED IN THE US.

    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. 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 INFECTION. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.160, LOT# 1702881 - STER. 1700147). SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.15.010, LOT# 1921256 - STER. 2000016). SMR REVERSE LINER +6 MM (PRODUCT CODE 1360.50.820, LOT# 19AT280 - STER. 1900420). SMR GLENOSPHERE 36MM (PRODUCT CODE 1374.09.111, LOT# 1916955 - STER. 1900376). SMR SMALL-R CONNECTOR +2 (PRODUCT CODE 1374.15.312, LOT# 1919129 - STER. 1900452). SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT# 1510923 - STER. 1500306). SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT# 1913111 - STER. 1900330). BONE SCREW 6,5 H.40MM (PRODUCT CODE 8420.15.050, LOT# 1611920 - STER. 1600227). BONE SCREW 6,5 H.40MM (PRODUCT CODE 8420.15.050, LOT# 1514608 - STER. 1500356). NO PROSTHESIS IMPLANTED. PREVIOUS REVISION SURGERY TOOK PLACE ON (B)(6) 2020. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348654 FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.16MM SMR CEMENTLESS FINNED STEM HSD LIMACORPORATE SPA 1304.15.160 1702881

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention