BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER #L FOR MOBILE LINER Ø42

    MDR report key: 15300885 · Received August 26, 2022

    Report

    Report Number
    3008021110-2022-00077
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    August 4, 2022
    Report Date
    August 26, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K181491
    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 ANOMALY ON THE 39 FEM. MODULAR HEAD - L Ø28MM THAT BELONG TO PRODUCT CODE 5010.42.283, LOT NUMBER 2183091, STERILIZATION NUMBER 2100243; NO PRE-EXISTING ANOMALY ON THE 56 MOBILE LINER ØINT 28 MM Ø42 MM THAT BELONG TO PRODUCT CODE 5566.50.420, LOT NUMBER 21AT1BV, STERILIZATION NUMBER 2100267; NO PRE-EXISTING ANOMALY ON THE 18 LINER #L FOR MOBILE LINER Ø42 PRODUCT CODE 5885.09.042, LOT NUMBER 2202030, STERILIZATION NUMBER 2200091. THEREFORE, WE CAN STATE THAT THE INVOLVED COMPONENTS WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL REPORT AFTER THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE STERILIZATION CHARTS OF THE INVOLVED DEVICES WERE CHECKED WITH THE FOLLOWING RESULTS: - NO PRE-EXISTING ANOMALY ON THE 39 FEM. MODULAR HEAD - L Ø28MM THAT BELONG TO PRODUCT CODE 5010.42.283, LOT NUMBER 2183091, STERILIZATION NUMBER (B)(4), - NO PRE-EXISTING ANOMALY ON THE 56 MOBILE LINER ØINT 28 MM Ø42 MM THAT BELONG TO PRODUCT CODE 5566.50.420, LOT NUMBER 21AT1BV, STERILIZATION NUMBER (B)(4), - NO PRE-EXISTING ANOMALY ON THE 18 LINER #L FOR MOBILE LINER Ø42 PRODUCT CODE 5885.09.042, LOT NUMBER 2202030, STERILIZATION NUMBER (B)(4). THEREFORE, WE CAN STATE THAT THE INVOLVED COMPONENTS WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO OTHER COMPLAINT DUE TO INFECTION IS REGISTERED IN OUR SYSTEM ON THE STERILIZATION LOTS INVOLVED (2100243, 2100267, 2200091). FEW INFORMATION IS AVAILABLE ON THIS CASE, SPECIFICALLY, THE FOLLOWING DETAILS WERE REQUESTED TO THE COMPLAINT SOURCE BUT NEVER PROVIDED: - GERM RESPONSIBLE FOR THE INFECTION, - PRE-OPERATIVE/POST OPERATIVE X-RAYS, - PATIENT'S CLINICAL DATA RELEVANT FOR THE ANALYSIS. WITHOUT FURTHER INFORMATION, A DEEPER ANALYSIS, OTHER THAN THE CHECK OF THE STERILIZATION CHARTS, IS NOT POSSIBLE AND THEREFORE WE CANNOT DETERMINE THE CAUSE OF THE INFECTION REPORTED. BASED ON THE STERILIZATION CHARTS CHECK, WE CAN STATE THAT THE DEVICES INVOLVED WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET AND THEREFORE CLASSIFY THIS EVENT AS NOT PRODUCT-RELATED. PMS DATA: BASED ON LIMACORPORATE'S PMS DATA, WITH REFERENCE TO THE LINERS FOR MOBILE LINERS (PRODUCT CODES 5885.09.040-042), WE CAN ESTIMATE A REVISION RATE OF ABOUT 0.05%. NO CORRECTIVE ACTION IS 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 PERFORMED ON (B)(6) 2022, DUE TO INFECTION. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022, DUE TO ASEPTIC LOOSENING. THE FOLLOWING IS THE LIST OF THE COMPONENTS INVOLVED: FEM. MODULAR HEAD - L Ø28MM (PRODUCT CODE 5010.42.283, LOT NUMBER 2183091, STERILIZATION NUMBER 2100243); MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420, LOT NUMBER 21AT1BV, STERILIZATION NUMBER 2100267); LINER #L FOR MOBILE LINER Ø42 (PRODUCT CODE 5885.09.042, LOT NUMBER 2202030, STERILIZATION NUMBER 2200091); THE COMPONENTS EXPLANTED WERE REPLACED WITH NEW COMPONENTS. THE PATIENT IS 86 YEARS OLD. EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022 AND WAS A TOTAL HIP REVISION SURGERY DUE TO ASEPTIC LOOSENING. THE COMPLAINT SOURCE REPORTED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE ABOUT THE PREVIOUS REVISION SURGERY. ACCORDING TO THE INFORMATION RECEIVED, DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2022, DAIR PROCEDURE WAS PERFORMED (DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION). THE FOLLOWING DEVICES WERE EXPLANTED AND REPLACED WITH NEW DEVICES OF THE SAME TYPE. - FEM. MODULAR HEAD - L Ø28MM (PRODUCT CODE 5010.42.283, LOT NUMBER 2183091, STERILIZATION NUMBER (B)(4)) - MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420, LOT NUMBER 21AT1BV, STERILIZATION NUMBER (B)(4)) - LINER #L FOR MOBILE LINER Ø42 (PRODUCT CODE 5885.09.042, LOT NUMBER 2202030, STERILIZATION NUMBER (B)(4)) THE PATIENT IS 86 YEARS OLD. THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436344 LINER #L FOR MOBILE LINER Ø42 LINER #L FOR MOBILE LINER DIA.42, LZO LIMACORPORATE S.P.A. 5885.09.042 2202030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention