BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM Ø21

    MDR report key: 8158956 · Received December 13, 2018

    Report

    Report Number
    3008021110-2018-00116
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    December 3, 2018
    Report Date
    August 28, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE STERILIZATION CHARTS: BY CHECKING THE STERILIZATION CHARTS OF THE LOT#S OF ALL THE COMPONENTS EXPLANTED, NO ANOMALY WAS FOUND ON THE OVERALL NUMBER OF COMPONENTS, THUS CONFIRMING THAT COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO EXPLANTS NOR X-RAYS WERE PROVIDED TO LIMACORPORATE. WITH THE VERY FEW INFO RECEIVED, A DEEPER INVESTIGATION ABOUT THIS CASE IS NOT POSSIBLE. STERILIZATION AND MANUFACTURING RECORDS OF ALL THE COMPONENTS INVOLVED WERE CHECKED AND THE BATCHES WERE MANUFACTURED/STERILIZED CORRECTLY UP TO SPECS AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS AND NO MANUFACTURING/STERILIZATION DEVIATIONS WERE REPORTED. EVENT NOT PRODUCT RELATED. PMS DATA: WE ARE AWARE OF A TOTAL OF 14 INFECTION CASES INVOLVING A SMR ANATOMIC HEMI PROSTHESIS. SPECIFIC INFECTION RATE= 0.069%. ALL THE CASES INVESTIGATE WERE NOT PRODUCT-RELATED. NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET.

    Description of Event or Problem · 0

    FIRST STAGE OF SHOULDER REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2018: REMOVAL OF ALL THE COMPONENTS PREVIOUSLY IMPLANTED ON (B)(6) 2009. THE INVOLVED COMPONENTS ARE THE FOLLOWING: SMR CEMENTLESS FINNED STEM Ø21 CODE 1304.15.210 LOT# 0903317 STER. 0900244; SMR HUMERAL HEAD Ø48 MM CODE 1322.09.480 LOT# 0902777 STER. 0900222; SMR ECC.ADAPTOR TAPER STANDARD CODE 1330.15.274 LOT# 0905105 STER. 0900269; SMR TRAUMA HUM. BODY # MEDIUM CODE 1350.15.010 LOT# 0904595 STER. 0900255. CEMENT SPACER WAS PUT IN. NO INFO REPORTED ABOUT A SECOND STAGE REVISION. ACCORDING TO THE INFO REPORTED, IT WILL BE (OR WAS) IMPLANTED A REVERSE SHOULDER PROSTHESIS NOT MANUFACTURED BY LIMACORPORATE. AT THE TIME OF COMPLAINT REPORTING, THE GERM RESPONSIBLE WAS NOT YET KNOWN: SAMPLES HAVE BEEN SENT FOR TESTING BUT NO ADDITIONAL INFO WAS PROVIDED TO LIMACORPORATE. NO KNOWLEDGE OF PREVIOUS CASES OF INFECTION FOR THIS PATIENT. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    WE CHECKED THE STERILIZATION CHARTS OF ALL THE INVOLVED COMPONENTS WITHOUT FINDING ANY ANOMALY, THUS WE CAN STATE THAT THESE COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    FIRST STAGE REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2018: REMOVAL OF ALL THE COMPONENTS PREVIOUSLY IMPLANTED. PREVIOUS SURGERY PERFORMED ON (B)(6) 2009. THE INVOLVED COMPONENTS ARE THE FOLLOWING: SMR CEMENTLESS FINNED STEM Ø21 CODE 1304.15.210 LOT# 0903317 STER. 0900244. SMR HUMERAL HEAD Ø48 MM CODE 1322.09.480 LOT# 0902777 STER. 0900222. SMR ECC. ADAPTOR TAPER STANDARD CODE 1330.15.274 LOT# 0905105 STER. 0900269. SMR TRAUMA HUM. BODY # MEDIUM CODE 1350.15.010 LOT# 0904595 STER. 0900255. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999808 SMR CEMENTLESS FINNED STEM Ø21 SMR CEMENTLESS FINNED STEM Ø21 HSD LIMACORPORATE SPA 1304.15.210 0903317

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention