BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 3.5MM HEX DRIVE

    MDR report key: 9438484 · Received December 9, 2019

    Report

    Report Number
    0001825034-2019-05504
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    November 12, 2019
    Report Date
    May 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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: 31-301322 ARCOS CON SZ B STD 70MM TRL RIAL 70MM 053440, 11-300818 ARCOS 18X150MM SPL TPR DIST M 469110. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AND INITIAL THA WITH COMPETITOR DEVICES ON AN UNKNOWN DATE. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. DURING THE REVISION SURGERY, THE SCREWDRIVER BROKE INSIDE THE TRIAL BODY TRYING TO ATTACH IT TO THE IMPLANTED STEM. THE TRIAL COULD NOT BE DISASSEMBLED FROM THE IMPLANT. THE FEMUR WAS FRACTURED WHILE TRYING TO REMOVE THE STEM. THERE WAS A SURGICAL DELAY OF 120 MINUTES. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235454 ARCOS 3.5MM HEX DRIVE INSTRUMENT KWA ZIMMER BIOMET, INC. N/A ZB171203

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE