BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD #M D.40MM

    MDR report key: 15697122 · Received October 29, 2022

    Report

    Report Number
    3008021110-2022-00112
    Event Type
    Injury
    Date Received
    October 29, 2022
    Date of Event
    October 7, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K182099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WE WILL COLLECT AND ANALYZE THE AVAILABLE INFORMATION AND SUBMIT THE FINAL REPORT AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    THE CHECK OF THE DEVICE HISTORY RECORDS CONFIRMED THE ABSENCE OF PRE-EXISTING ANOMALIES ON THE DEVICES INVOLVED (LOT 2183361 STER. 2100282 AND LOT 7011680281), THEREFORE WE CAN STATE THEY HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE AVAILABLE X-RAYS AND INFORMATION WERE SHARED WITH OUR MEDICAL CONSULTANT, HE COMMENTED THE FOLLOWING: "INFECTIONS HAPPEN AND NOBODY IS TO BE BLAMED. IN CASE OF EARLY INFECTION (WITHIN 3 WEEKS AFTER PRIMARY) RETENTION OF WELL FIXED IMPLANTS GENERALLY IS CONSIDERED ACCEPTABLE, LATER ON EXCHANGE OF ALL IMPLANTS IS ADVISED. SUCH THE TREATMENT BY THE SURGEON HAS BEEN CORRECT." IN CONCLUSION, WE CANNOT DETERMINE WITH CERTAINTY THE CAUSE OF THE INFECTION REPORTED, HOWEVER IT APPEARS TO BE CAUSED BY FACTORS NOT RELATED TO THE PRODUCT THEMSELVES. THIS EVENT IS THEREFORE CLASSIFIED AS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF CERAMIC FEMORAL HEADS (FAMILY CODES 5010.42.XXX) DUE TO INFECTION IS 0.01%. 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) 2022. ACCORDING TO THE INFORMATION RECEIVED, THE ACETABULAR CUP AND THE STEM WERE NOT REMOVED AS THEY WERE WELL INTEGRATED, WHILE THE FEMORAL HEAD WITH CODE 5010.42.402, LOT 2183361, STER. 2100282 AND THE LINER WITH CODE 5885.42.262, LOT 7011680281 WERE REPLACED. THE PREVIOUS SURGERY DATE IS (B)(6) 2022. EVENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO EARLY INFECTION PERFORMED ON (B)(6) 2022. ACCORDING TO THE INFORMATION RECEIVED, THE ACETABULAR CUP (PRODUCT CODE 5552.15.140, LOT 2211826) AND THE FEMORAL STEM (CODE 4504.21.040, LOT NOT KNOWN) WERE NOT REMOVED AS THEY WERE WELL INTEGRATED, WHILE THE FEMORAL HEAD WITH CODE 5010.42.402, LOT 2183361, STER. 2100282 AND THE LINER WITH CODE 5885.42.262, LOT 7011680281 WERE REPLACED. THE PREVIOUS SURGERY DATE IS (B)(6) 2022. THE COMPLAINT SOURCE REPORTED THAT THE PATIENT IS 44 YEARS OLD, SUFFERING FROM ALCOHOLISM SEQUELAE. PRESENTED WOUND DEHISCENCE WITHIN THE FIRST 10 DAYS AFTER SURGERY. ISOLATED 1 OF 5 SAMPLES FOR S. CAPITIS R TO FOSFOMYCIN AND RIFAMPIN, 2 SAMPLES POSITIVE FOR K. PNEUMONIAE TOTI-S. THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2795576 FEM. MODULAR HEAD #M D.40MM FEMORAL HEADS (BIOLOX®DELTA) DIA. 40MM #M LPH LIMACORPORATE S.P.A. 5010.42.402 2183361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention