BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA-TT ACETAB.CUP Ø52 MM

    MDR report key: 15435512 · Received September 16, 2022

    Report

    Report Number
    3008021110-2022-00082
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    July 27, 2022
    Report Date
    September 16, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    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 41 H-MAX S STANDARD FEM. STEM #14 THAT BELONG TO PRODUCT CODE 4250.20.140, LOT NUMBER 2202209, STERILIZATION NUMBER 2200097. NO PRE-EXISTING ANOMALY ON THE 234 FEM. MODULAR HEAD - S Ø36MM THAT BELONG TO PRODUCT CODE 5010.42.361, LOT NUMBER 7011676347. NO PRE-EXISTING ANOMALY ON THE 55 DELTA-TT ACETAB.CUP Ø52 MM THAT BELONG TO PRODUCT CODE 5552.15.520, LOT NUMBER 2209021, STERILIZATION NUMBER 2200145. NO PRE-EXISTING ANOMALY ON THE 68 DELTA LINER ØINT 36MM # MEDIUM THAT BELONG TO PRODUCT CODE 5885.42.258, LOT NUMBER 7011690754. 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 41 H-MAX S STANDARD FEM. STEM #14 THAT BELONG TO PRODUCT CODE 4250.20.140, LOT NUMBER 2202209, STERILIZATION NUMBER 2200097. - NO PRE-EXISTING ANOMALY ON THE 234 FEM. MODULAR HEAD - S Ø36MM THAT BELONG TO PRODUCT CODE 5010.42.361, LOT NUMBER 7011676347. - NO PRE-EXISTING ANOMALY ON THE 55 DELTA-TT ACETAB.CUP Ø52 MM THAT BELONG TO PRODUCT CODE 5552.15.520, LOT NUMBER 2209021, STERILIZATION NUMBER 2200145. - NO PRE-EXISTING ANOMALY ON THE 68 DELTA LINER ØINT 36MM # MEDIUM THAT BELONG TO PRODUCT CODE 5885.42.258, LOT NUMBER 7011690754. TO PERFORM A DEEPER ANALYSIS, THE FOLLOWING INFORMATION WERE REQUESTED TO THE COMPLAINT SOURCE: - X-RAYS. - INFORMATION ON THE GERM RESPONSIBLE FOR THE INFECTION. - ADDITIONAL INFORMATION ABOUT THE SUSPECT OF PRE-EXISTING INFECTION SIGNALED BY THE COMPLAINT SOURCE, - PATIENT'S CLINICAL INFORMATION RELEVANT FOR THE ANALYSIS. THE COMPLAINT SOURCE COULD ONLY SHARE THE RADIOGRAPH TAKEN ON (B)(6), THUS BEFORE THE SURGERY DATED (B)(6) 2022. THE ONLY AVAILABLE RADIOGRAPH WAS SHARED WITH OUR MEDICAL CONSULTANT, WHO COMMENTED: "THE X-RAY, (B)(6) 2022, SHOWS A PREFORMED SPACER THAT IS ONLY USED FOR TEMPORARY STABILIZATION AFTER INFECTION. I UNDERSTAND THAT THERE HAS BEEN RE-IMPLANTATION (B)(6). OBVIOUSLY INTO A STILL INFECTED SITE, THAT REQUIRED RE-REVISION SOME 2 WEEKS LATER. UNFORTUNATELY, IT MUST BE FEARED THAT INFECTION MAY STILL BE GOING ON AS THE LAST IMPLANTS WERE NOT EXCHANGED." IN CONCLUSION: - THE STERILIZATION CHARTS OF THE INVOLVED DEVICES CONFIRMED THAT THEY WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET, - BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION PERFORMED, INFECTION WAS PROBABLY ALREADY PRESENT BEFORE IMPLANTATION OF LIMA DEVICES. ON THE BASIS OF THE ANALYSES PERFORMED, THE CAUSE OF THE INFECTION CANNOT BE DETERMINED WITH CERTAINTY, HOWEVER IT SEEMS TO BE LINKED TO OTHER FACTORS NOT RELATED TO THE DEVICES THEMSELVES. EVENT CLASSIFIED AS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE A REVISION RATE OF DELTA TT CUPS (FAMILY CODES 5552.15.XXX) DUE TO INFECTION OF ABOUT 0.02%. 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

    SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED. THE IMPLANT WAS LEFT IN SITU. THE FOLLOWING IS THE LIST OF THE COMPONENTS INVOLVED: H-MAX S STANDARD FEM. STEM #14 (PRODUCT CODE 4250.20.140, LOT NUMBER 2202209, STERILIZATION NUMBER 2200097). FEM. MODULAR HEAD - S Ø36MM (PRODUCT CODE 5010.42.361, LOT NUMBER 7011676347). DELTA-TT ACETAB.CUP Ø52 MM (PRODUCT CODE 5552.15.520, LOT NUMBER 2209021, STERILIZATION NUMBER 2200145). DELTA LINER ØINT 36MM # MEDIUM (PRODUCT CODE 5885.42.258, LOT NUMBER 7011690754, PRODUCT NOT SOLD IN US). THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2022. THE PATIENT IS 41 YEARS OLD. EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED. THE IMPLANT WAS LEFT IN SITU. THE FOLLOWING IS THE LIST OF THE COMPONENTS INVOLVED: - H-MAX S STANDARD FEM. STEM #14 (PRODUCT CODE 4250.20.140, LOT NUMBER 2202209, STERILIZATION NUMBER 2200097). - FEM. MODULAR HEAD - S Ø36MM (PRODUCT CODE 5010.42.361, LOT NUMBER 7011676347). - DELTA-TT ACETAB.CUP Ø52 MM (PRODUCT CODE 5552.15.520, LOT NUMBER 2209021, STERILIZATION NUMBER 2200145). - DELTA LINER ØINT 36MM # MEDIUM (PRODUCT CODE 5885.42.258, LOT NUMBER 7011690754). THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2022. THE COMPLAINT SOURCE STATED THAT THEY COULD NOT EXCLUDE THAT THE INFECTION WAS ALREADY PRESENT. THE PATIENT IS 41 YEARS OLD. EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875067 DELTA-TT ACETAB.CUP Ø52 MM ACETABULAR CUPS (TI6AL4V) DIA. 52MM FOR LINER SIZE LPH LIMACORPORATE S.P.A. 5552.15.520 2209021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention