BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION MOD. STEM Ø24MM

    MDR report key: 15649265 · Received October 21, 2022

    Report

    Report Number
    3008021110-2022-00096
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 15, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K151739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE STERILIZATION CHARTS, NO PRE-EXITING ANOMALY WAS DETECTED ON THE DEVICES RELEASED WITH THE LOT NUMBERS INVOLVED, THEREFORE WE CAN STATE THAT THEY HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. BASED ON THE FEW AVAILABLE INFORMATION, WE CANNOT FURTHER INVESTIGATE THE CAUSE OF THE INFECTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE (SUCH AS THE GERM RESPONSIBLE OF THE REPORTED INFECTION, THE PRE-OPERATIVE X-RAYS) BUT IT WAS NOT AVAILABLE. IN CONCLUSION, WE COULD ONLY PERFORM THE CHECK OF THE STERILIZATION CHARTS OF THE DEVICES INVOLVED, WHICH CONFIRMED THE ABSENCE OF PRE-EXISTING ANOMALIES ON THESE LOT NUMBERS. BASED ON THE STERILIZATION CHARTS ANALYSIS, WE CANNOT CLASSIFY THIS INCIDENT AS PRODUCT RELATED. CONSIDERING THE FEMORAL IMPLANT (STARDARD DEVICE: REVISION HIP SYSTEM), ON THE BASIS OF LIMACORPORATE PMS DATA, WE ESTIMATE A REVISION RATE 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. NOTE: PLEASE NOTE THAT THIS IS AN INITIAL-FINAL COMBINED MDR.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON THE (B)(6) 2022. THE PREVIOUS SURGERY TOOK PLACE ON JULY 2ND 2019. THE PROSTHESIS INVOLVED IS COMPOSED BY A CUSTOM-MADE ACETABULAR IMPLANT (CMD 19-1112 ACETABULAR IMPLANT, PRODUCT CODE 961714862, LOT 1910355, STER. 1900240) AND THE FOLLOWING STANDARD DEVICES: REVISION MOD. STEM Ø24MM PRODUCT CODE 382015010 LOT N.1704823 STER.1700152, FEM. MODULAR HEAD - M Ø28MM PRODUCT CODE 501042282 LOT N.1881148 STER.1800273, MOBILE LINER ØINT 28 MM Ø40 MM PRODUCT CODE 556650401 LOT N.18AT299 STER.1900008, LINER #M FOR MOB. LINER Ø40 PRODUCT CODE 588509040 LOT N.1818322 STER.1900049, DELTA ANGLED SPACER 20°# L PRODUCT CODE 588615510 LOT N. 1815716 STER.1800366, REVISION LATER. NECK H.60MM PRODUCT CODE 751515110 LOT N. 1819747 STER. 1900046, BONE SCREW Ø6,5 H.35MM PRODUCT CODE 842015040 LOT N. 1908033 STER.1900219, BONE SCREW Ø6,5 H.35MM PRODUCT CODE 842015040 LOT N. 1909131 STER. 1900230, BONE SCREW Ø6,5 H.45MM PRODUCT CODE 842015060 LOT N. 1906273 STER. 1900189, BONE SCREW Ø6,5 H.80MM PRODUCT CODE 842015130 LOT N. 1709469 STER.1800037, DURING THE REVISION SURGERY, ALL THE DEVICES WERE EXPLANTED AND AN ANTIBIOTIC SPACER WAS INSERTED. PATIENT IS MALE. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021884 REVISION MOD. STEM Ø24MM REVISION STEM DIA. 24 MM, L. 140 MM LZO LIMACORPORATE S.P.A. 3820.15.010 1704823

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention