BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION FEMORAL SYSTEM

    MDR report key: 18985264 · Received March 27, 2024

    Report

    Report Number
    3008021110-2024-00026
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 27, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K151739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE STERILIZATION CHARTS OF THE INVOLVED DEVICES WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALIES DETECTED ON THE 40 REVISION MOD. STEMS Ø16MM PRODUCT CODE 3812.15.010, LOT 2022340, STER. 2100003, NO PRE-EXISTING ANOMALIES DETECTED ON THE 30 REVISION LATER. NECKS H.70MM PRODUCT CODE 7515.15.120UD (MDD), LOT 2008125, STER. 2000245. THEREFORE, WE CAN STATE THEY HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT WAS NEVER PROVIDED: PATHOGEN RESPONSIBLE FOR THE INFECTION. RADIOGRAPHS. PATIENT'S CLINICAL DATA. PRODUCT DETAILS OF THE OTHER EXPLANTED DEVICES. ADDITIONAL DETAILS REFERRING TO THE PREVIOUS SURGERY WITHOUT THIS INFORMATION WE CANNOT PERFORM ANY FURTHER INVESTIGATION, OTHER THAN THE CHECK OF THE STERILIZATION CHARTS OF THE REVISION STEM AND NECK INVOLVED. NO DEFINITIVE CONCLUSION CAN BE DETERMINED ON THE CAUSE OF INFECTION, HOWEVER, BASED ON THE ANALYSES PERFORMED, WE CLASSIFY THIS EVENT AS NOT PRODUCT RELATED. PMS DATA: BASED ON LIMACORPORATE PMS DATA, WE CAN ESTIMATE A REVISION RATE DUE TO INFECTION OF THE REVISION STEMS OF ABOUT (B)(4). NO CORRECTIVE ACTION NEEDED FOLLOWING THIS COMPLAINT, LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF INVOLVED LOT NUMBERS, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS MANUFACTURED WITH THOSE LOT NUMBERS. THEREFORE, ALL THE PRODUCTS WITH THOSE LOT NUMBERS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL REPORT AFTER THE FINAL INVESTIGATION.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO ACUTE PERIPROSTHETIC HIP INFECTION IN FEMORAL STEM REVISION. TOTAL HIP PROSTHESIS WAS EXPLANTED. THE FOLLOWING DEVICES EXPLANTED: REVISION MOD. STEM Ø16MM (PRODUCT CODE: 3812.15.010, LOT. 2022340 - STER.2100003). REVISION LATER. NECK H.70MM (PRODUCT CODE: 7515.15.120, - LOT. 2008125 - STER. 2000245). PRODUCT CODE NUMBER AND LOT NUMBER OF EXPLANTED CUP, LINER, HEAD, AND SCREW ARE UNKNOWN. THE EXACT IMPLANT DATE OF DEVICES IS UNKNOWN (APPROXIMATELY TWO WEEKS BEFORE THE CURRENT REVISION). PATIENT AGE: 73 YEARS OLD. THIS EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO ACUTE PERIPROSTHETIC HIP INFECTION IN FEMORAL STEM REVISION. TOTAL HIP PROSTHESIS WAS EXPLANTED. THE FOLLOWING DEVICES EXPLANTED: REVISION MOD. STEM Ø16MM (PRODUCT CODE: 3812.15.010, LOT. 2022340 - STER.2100003). REVISION LATER. NECK H.70MM (PRODUCT CODE: 7515.15.120, - LOT. 2008125 - STER. 2000245). PRODUCT CODE NUMBER AND LOT NUMBER OF EXPLANTED CUP, LINER, HEAD, AND SCREW ARE UNKNOWN. THE EXACT IMPLANT DATE OF DEVICES IS UNKNOWN (APPROXIMATELY TWO WEEKS BEFORE THE CURRENT REVISION). PATIENT AGE: 73 YEARS OLD. EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129864 REVISION FEMORAL SYSTEM 2. COMMON DEVICE NAME REVISION STEM DIA. 16 MM, L. 140 MM, LZO LIMACORPORATE S.P.A. 3812.15.010 2022340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention