BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMA S FEMORAL STEM LATERALIZING #7

    MDR report key: 17304824 · Received July 12, 2023

    Report

    Report Number
    3008021110-2023-00083
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    June 26, 2023
    Report Date
    July 12, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THESE LOT NUMBERS (2219541, 7011794800, 7011782239). WE WILL PROCEED WITH FURTHER INVESTIGATIONS AND SUBMIT THE FINAL REPORT AS SOON AS THE ANALYSIS WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALIES WERE DETECTED BY THE CHECK OF THE STERILIZATION CHARTS OF THE LOT NUMBERS INVOLVED. THIS IS THE FIRST AND ONLY COMPLAINT REGISTERED ON THESE LOT NUMBERS (2219541 STER. 2200288, 7011794800, 7011782239). TO PERFORM A CLINICAL EVALUATION BY A MEDICAL CONSULTANT, RADIOGRAPHS WERE REQUESTED TO THE COMPLAINT SOURCE BUT WERE NOT AVAILABLE. WITHOUT THE POSSIBILITY TO ANALYZE THE X-RAYS NO FURTHER ANALYSIS CAN BE PERFORMED, OTHER THAN THE CHECK OF THE STERILIZATION CHARTS, WHICH CONFIRMED THAT THE DEVICES WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. IN CONCLUSION, WE CANNOT DETERMINE WITH CERTAINTY THE CAUSE OF THE INFECTION REPORTED, HOWEVER IT DOES NOT SEEM TO BE PRODUCT RELATED. PMS DATA BASED ON LIMACORPORATE PMS DATA, WE CAN ESTIMATE A REVISION RATE OF MINIMA S STEMS (FAMILY CODES 4504.21.XXX/4503.21.XXX) OF ABOUT (B)(4). NO CORRECTIVE ACTION NEEDED FOLLOWING THIS COMPLAINT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO EARLY INFECTION PERFORMED ON (B)(6) 2023. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. DURING THE REVISION SURGERY, THE FOLLOWING DEVICES WERE EXPLANTED: MINIMA S LATERALIZED STEM #7 CODE 4504.21.070 LOT 2219541 STER 2200288; FEM. MODULAR HEAD - M Ø36MM CODE 5010.42.362 LOT 7011794800; DELTA LINER ØINT 36MM # LARGE CODE 5885.42.260 LOT 7011782239; THE DELTA-TT ACETAB.CUP Ø54 MM (CODE 555215540, LOT 2222651) WAS WELL FIXED AND WAS NOT REMOVED. THE PATIENT IS 56 YEARS OLD. THIS EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO EARLY INFECTION PERFORMED ON (B)(6) 2023. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. DURING THE REVISION SURGERY, THE FOLLOWING DEVICES WERE EXPLANTED: - MINIMA S LATERALIZED STEM #7 CODE 4504.21.070 LOT 2219541 STER 2200288 - FEM. MODULAR HEAD - M Ø36MM CODE 5010.42.362 LOT 7011794800 - DELTA LINER ØINT 36MM # LARGE CODE 5885.42.260 LOT 7011782239 THE DELTA-TT ACETAB.CUP Ø54 MM (CODE 5552.15.540, LOT 2222651) WAS WELL FIXED AND WAS NOT REMOVED. IT WAS REPORTED THAT THE FOLLOWING GERM WAS ISOLATED: STREPTOCOCCUS DYSGALACTIAE SENSITIVE TO AMOXICILLIN. THE PATIENT IS 56 YEARS OLD, NORMAL BMI, NO OTHER PATHOLOGIES REPORTED. SUSPECTED DENTAL INFECTION WAS REPORTED RETROSPECTIVELY. THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233251 MINIMA S FEMORAL STEM LATERALIZING #7 MINIMA S FEMORAL STEM LATERALIZING #7 LZO LIMACORPORATE S.P.A. 4504.21.070 2219541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention