BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 19X190MM SPL TPR DIST

    MDR report key: 8949835 · Received August 30, 2019

    Report

    Report Number
    0001825034-2019-03816
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    July 22, 2019
    Report Date
    November 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 OPERATIVE NOTES. OPERATIVE NOTES WERE REVIEWED BY A HEALTH PROFESSIONAL WHICH INDICATED THAT UPON TRIALING THE STEM, CORTICAL PERFORATION OCCURRED AND WAS CONFIRMED WITH XRAY. ADDITIONAL TWO CABLES WERE PLACED DISTAL TO PERFORATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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: BIOMET CONE, CAT#11-301310, LOT#854340; BIOMET TAPER, CAT#650-1064, LOT#2958902; BIOMET HEAD, CAT#650-1057, LOT#2970977; ZIMMER LINER, CAT#00630505036, LOT#64399195; ZIMMER CUP, CAT#00620005222, LOT#63236986. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 3 YEARS LATER DUE TO PAIN AND ASEPTIC LOOSENING OF THE FEMORAL STEM WITH SURROUNDING CORTICAL REMODELING. WHILE TRIALING THE FEMORAL STEM, CORTICAL PERFORATION WAS NOTED AT THE DISTAL TIP. CERCLAGE WIRES WERE USED TO STABILIZE THE FRACTURE WHILE BONE PUTTY WAS USED FOR REPAIR. THE FINAL STEM WAS IMPLANTED WITHOUT FURTHER COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744922 ARCOS 19X190MM SPL TPR DIST PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 351640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other