BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM. MODULAR HEAD - L Ø28MM

    MDR report key: 16145792 · Received January 12, 2023

    Report

    Report Number
    3008021110-2023-00001
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 30, 2022
    Report Date
    April 20, 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

    BY THE CHECK OF THE DEVICE HISTORY RECORDS OF THE LOT NUMBER INVOLVED, NO ANOMALY WAS DETECTED. INVESTIGATION IS CURRENTLY ONGOING, A FINAL REPORT WILL BE SUBMITTED AS SOON AS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION DURING THE PRELIMINARY INVESTIGATION, THE MANUFACTURING CHARTS OF THE CERAMIC FEMORAL HEAD WITH CODE 5010.42.283, LOT NUMBER 1581651, STERILIZATION NUMBER 2200243 AND OF THE METAL FEMORAL HEAD WITH CODE 5010.09.284, LOT NUMBER 1203396, STERILIZATION NUMBER 2200243 WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS FOUND. BOTH THE FEMORAL HEADS WERE RE-WORKED AND ASSOCIATED TO THE SAME STERILIZATION LOT 2200243. EACH WORK ORDER IS COMPOSED BY ONE SINGLE ITEM. THE TWO HEADS WERE WASHED TOGETHER, AND THE SUBSEQUENT PHASES WERE PERFORMED WITH A DIFFERENCE OF 5-6 MINUTES WITH ONE EACH OTHER. FOR THIS REASON, WE CAN RECKON THAT THE MISMATCH IS RELATED TO A HUMAN MISTAKE. THEREFORE, A CORRECTIVE ACTION PREVENTIVE ACTION (CAPA), WITH INTERNAL CODE (B)(4), WAS OPENED TO REDUCE THE RISK OF RECURRENCE OF SIMILAR NON-CONFORMITIES. MOREOVER , LIMA CORPORATE PERFORMED THE RECALL OF THE CERAMIC FEMORAL HEAD INSIDE THE PACKAGING OF A METAL FEMORAL HEAD THAT WAS STILL ON THE FIELD, THROUGH A FIELD SAFETY CORRECTIVE ACTION (FSCA) CLOSED ON MARCH 17TH,2023. THE FSCA ABOVE-MENTIONED DOES NOT INCLUDE A DEVICE WITH A COMBINATION OF PRODUCT CODE AND LOT NUMBER MANUFACTURED OR DISTRIBUTED IN UNITED STATES; FOR THIS REASON, NO FURTHER REPORT WAS SUBMITTED TO THE FDA FOR THE FIELD ACTION. PMS DATA ACCORDING TO THE RELEVANT PMS DATA, THE OCCURRENCE RATE OF THIS TYPE OF ISSUES RELATED TO THE FEMORAL HEADS BELONGING TO THE FAMILY CODE 5010.42.XXX IS ABOUT (B)(4)%. FOR THIS COMPLAINT, A SPECIFIC FIELD SAFETY CORRECTIVE ACTION (FSCA) WAS PERFORMED, AS DESCRIBED IN THE ABOVE SECTION (NO FDA RELEVANT). LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    INSIDE THE PACKAGE OF THE CERAMIC FEMORAL HEAD L Ø28MM WITH CODE 5010.42.283 LOT 1581651 STER. 2200243, A METAL FEMORAL HEAD WAS FOUND (5010.09.284 LOT. 1203396). THE SURGERY WAS POSITIVELY COMPLETED WITH FEW MINUTES OF DELAY, A 28MM MEDIUM CERAMIC HEAD WAS IMPLANTED. THE INCIDENT OCCURRED IN ITALY.

    Description of Event or Problem · 0

    DURING A HIP SURGERY PERFORMED ON (B)(6) 2022, INSIDE THE PACKAGE OF THE CERAMIC FEMORAL HEAD L Ø28MM WITH CODE 5010.42.283 LOT 1581651 STER. 2200243, A METAL FEMORAL HEAD WAS FOUND (5010.09.284 LOT. 1203396). THE SURGERY WAS POSITIVELY COMPLETED WITH FEW MINUTES OF DELAY, A 28MM MEDIUM CERAMIC HEAD WAS IMPLANTED . THE INCIDENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635523 FEM. MODULAR HEAD - L Ø28MM BIOLOX DELTA HEAD 28MM #L LZO LIMACORPORATE S.P.A. 5010.42.283 1581651

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other