BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0001825034-2019-01254

    MDR report key: 8432149 · Received March 19, 2019

    Report

    Report Number
    0001825034-2019-01254
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    May 16, 2018
    Report Date
    April 11, 2019
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVISION NOTES STATE THAT THERE WAS DIFFICULTY THREADING THE EXTRACTOR INTO THE IMPLANT. WHEN A TRIAL EXTRACTION WAS PERFORMED, IT WAS UNSUCCESSFUL AND IT WAS IMMEDIATELY NOTED THAT THERE WAS AN INSUFFICIENCY OF BONE ALONG THE MEDICAL CALCAR. THERE WAS DISRUPTION OF THE ANTERIOR BONE UPON THE STEM REMOVAL, AND THE FEMORAL FRACTURE WAS THUS STABILIZED WITH CABLES. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE REMAINS UNDETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157854, M2A-MAGNUM PF CUP 54ODX48ID, , 346150; 157448, M2A-MAGNUM MOD HD SZ 48MM, 651280; 139258, M2A-MAGNUM 42-50M TPR INSRT +3, 91910; 14-103203, TAPERLOC MICROP FMRL 9.0MM, 625730. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08980. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [PRODUCT LOCATION UNKNOWN]. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REVISION PROCEDURE, THE SURGEON REMOVED ALL OF THE PRIOR COMPONENTS BUT HAD DIFFICULTY REMOVING THE STEM. IT WAS STATED THAT THE INSTRUMENT WOULD NOT THREAD INTO THE IMPLANT, WHICH CONTRIBUTED TO THE DIFFICULTY REMOVING THE STEM RESULTING IN THE FRACTURE HER PROXIMAL RIGHT FEMUR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1