BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULUS-STRUM. - ESTRATTORE

    MDR report key: 12370006 · Received August 26, 2021

    Report

    Report Number
    3008021110-2021-00064
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 23, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWY
    PMA / PMN Number
    K112158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    DURING HIP REVISION SURGERY PERFORMED ON (B)(6) 2021, THE SURGEON TRIED TO REMOVE ONLY THE MODULUS NECK L TAPER B 12/14 (PRODUCT CODE 7590.15.040, LOT #1915537), HOWEVER HE EXPERIENCED DIFFICULTIES IN REMOVING IT. ACCORDING TO THE COMPLAINT SOURCE, THE EXTRACTOR MODULUS-STRUM. - ESTRATTORE (PRODUCT CODE 9043.10.360, LOT #1401263) WAS STIFF. IN THE ORIGINAL PLAN, THE STEM WAS NOT LOOSENED, AND WAS GOING TO REMAIN IMPLANTED. HOWEVER, DUE TO THE ENCOUNTERED ISSUES IN REMOVING THE NECK, IT WAS REPORTED THAT THE SURGEON DECIDED TO REMOVE THE MODULUS MODULAR STEM Ø22 MM (PRODUCT CODE 4310.15.100, LOT #1901684) TOGETHER WITH THE NECK TO CONCLUDE SURGERY. ADDITIONALLY DURING SURGERY, ACCORDING TO THE COMPLAINT SOURCE, SURGEON TURNED THE WRENCH ZIMMER CONNECTION H210MM (PRODUCT CODE 9095.10.131, LOT #15AG0TP) WITH STRONG STRENGTH RESULTING IN BREAKAGE AT THE JUNCTION BETWEEN THE T-HANDLE AND THE EXTRACTOR. IT WAS REPORTED THAT SURGERY WAS PROLONGED OF ABOUT 2 HOURS. PATIENT IS A FEMALE, (B)(6). EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272703 MODULUS-STRUM. - ESTRATTORE NECK EXTRACTOR KWY LIMACORPORATE S.P.A. 9043.10.360 1401263

    Patients

    Seq Age Sex Outcome Treatment
    1 Other