BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 8397965 · Received March 7, 2019

    Report

    Report Number
    3008021110-2019-00025
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    February 26, 2019
    Report Date
    June 25, 2019
    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

    CHECK OF THE DHR: BY CHECKING THE STERILIZATION CHARTS OF THE LOTS INVOLVED, NO PREEXISTING ANOMALY WAS FOUND: ON A TOTAL OF (B)(4) STEMS MANUFACTURED WITH LOT #1402847, STER. #1400120; ON A TOTAL OF 63 REVERSE HUMERAL BODIES MANUFACTURED WITH LOT #1500016, STER. #1500043; ON A TOTAL OF (B)(4) REVERSE LINERS MANUFACTURED WITH LOT #1800141 STER. #1800055; ON A TOTAL OF (B)(4) CONNECTORS MANUFACTURED WITH LOT #1802197, STER. #1800069; ON A TOTAL OF (B)(4) HP GLENOSPHERES MANUFACTURED WITH LOT #1814900, STER. #1800319; ON A TOTAL OF (B)(4) GLENOIDS MANUFACTURED WITH LOT #1503447, STER. #1500135; THEREFORE, WE CAN STATE THAT THE OVERALL COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: NO EXPLANTS AVAILABLE FOR FURTHER ANALYSIS. PICTURES OF THE EXPLANTS RECEIVED SHOW BONE GROWTH ON THE STEM AND ON THE GLENOID METAL BACK PEG. XRAYS ANALYSIS: XRAY IMAGES WERE NOT AVAILABLE FOR A CLINICAL EVALUATION. ACCORDING TO THE INFO REPORTED, INFECTION WAS CAUSED BY P. ACNES AND OTHER BACTERIA. WITH THE ONLY FEW INFO RECEIVED AND BASED ON OUR ANALYSIS, WE CANNOT ESTIMATE A CERTAIN ROOT CAUSE FOR THE INFECTION REPORTED. BY OUR STERILIZATION CHARTS CHECK, ALL THE COMPONENTS IMPLANTED ON (B)(6) 2015 AND (B)(6) 2019 HAVE BEEN CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. CASE NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, SMR REVERSE REVISION RATE DUE TO INFECTION IS (B)(4). NONE OF THE CASES WE COULD INVESTIGATE WERE CLASSIFIED AS PRODUCT RELATED. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 0

    SECOND SMR REVERSE REVISION SURGERY DUE TO INFECTION CAUSED BY P. ACNES AND OTHER BACTERIA PERFORMED ON (B)(6) 2019. PATIENT CLINICAL HISTORY CAN BE SUMMARIZED AS PER FOLLOWING: PRIMARY SURGERY TOOK PLACE ON (B)(6) 2015. FIRST SMR REVERSE REVISION SURGERY OCCURRED ON (B)(6) 2019 AND WAS ALSO DUE TO INFECTION (EVENT ASSOCIATED TO LIMA CORPORATE COMPLAINT #60/19 MFR 3008021110201900023). DURING CURRENT SURGERY SECOND SMR REVERSE REVISION THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR CEMENTLESS FINNED STEM (CODE #1304.15.210; LOT # 1402847); SMR REVERSE FINNED HUMER. BODY (CODE #1352.15.050; LOT #1500016); SMR REVERSE HP LINER LONG (CODE #1365.09.020; LOT #1800141); SMR CONNECTOR SMALL STD (CODE #1374.15.310; LOT #1802197); SMR REVERSE HP GLENOSPH. 40 MM (CODE #1374.50.400; LOT #1814900); SMR UNCEMENT. GLENOID # STD (CODE #1375.20.010; LOT #1503447). DURING THE FIRST REVISION SURGERY (ASSOCIATED TO TGA# 56139), GLENOSPHERE DIA. 40MM (CODE #1374.50.400, LOT#1506244), TAPER (CODE #1374.15.310, LOT#1504982), AND REVERSE LINER (CODE #1365.09.020, LOT# 1414479) PREVIOUSLY IMPLANTED WERE REMOVED, WHEREAS STEM, REVERSE BODY, METAL BACK AND SCREWS WERE LEFT IN SITU. SURGEON CONDUCTED AN EXTENSIVE WASHOUT AND REPLACED COMPONENTS + ANTIBACTERIAL TREATMENT. UNFORTUNATELY, THE ANTIBACTERIAL TREATMENT ADMINISTERED FROM POST FIRST REVISION WAS UNSUCCESSFUL AND HENCE THE SURGEON DECIDED (BY VIRTUE OF PATIENT CONDITION) TO REMOVAL ALL COMPONENTS ON (B)(6) 2019. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE LOT#S INVOLVED (LOT #1402847, STER. #1400120; LOT #1500016, STER. #1500043; LOT #1800141 STER. #1800055, LOT #1802197, STER. #1800069; LOT #1814900, STER. #1800319; LOT #1503447, STER. #1500135), NO ANOMALY WAS FOUND, THUS WE CAN STATE THAT THESE COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL PROVIDE A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION BY P. ACNES AND OTHER BACTERIA OCCURRED ON (B)(6) 2019. PREVIOUS SURGERY OCCURRED ON THE (B)(6) 2019 DUE TO THE SAME INFECTION. DURING CURRENT SURGERY, THE ENTIRE PROSTHESIS WAS REMOVED, IN PARTICULAR THE COMPONENTS SMR CEMENTLESS FINNED STEM (CODE #1304.15.210; LOT # 1402847); SMR REVERSE FINNED HUMER. BODY (CODE #1352.15.050; LOT #1500016); SMR REVERSE HP LINER LONG (CODE #1365.09.020; LOT #1800141); SMR CONNECTOR SMALL STD (CODE #1374.15.310; LOT #1802197); SMR REVERSE HP GLENOSPH. 40 MM (CODE #1374.50.400; LOT #1814900); SMR UNCEMENT. GLENOID # STD (CODE #1375.20.010; LOT #1503447). IN THE PREVIOUS SURGERY, SURGEON DID NOT REMOVE ALL THE COMPONENTS BECAUSE HE HOPED TO REMOVE JUST THOSE MAY HAD BEEN HARBOURING THE INFECTION. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2015. EVENT OCCURRED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194608 SMR CEMENTLESS FINNED STEM SMR CEMENTLESS FINNED STEM (HSD-KWT) HSD LIMACORPORATE SPA 1304.15.210 1402847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention