BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM

    MDR report key: 7752428 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05854
    Event Type
    Injury
    Date Received
    August 6, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 11-301212 ¿ ARCOS MODULAR REVISION SYSTEM CALCAR PROXIMAL BODY HIGH OFFSET STEM ¿ 984310; UNKNOWN ¿ ZIMMER TM SHELL ¿ UNKNOWN; UNKNOWN ¿ ZIMMER TRILOGY LONGEVITY ¿ UNKNOWN; UNKNONW ¿ SELEX M2A MAGNUM TYPE 1 TAPER - UNKNOWN; THEREAPY DATE IS UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -05852.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS FOUND TO HAVE TROCHANTERIC BURSITIS AT AN UNKNOWN AMOUNT OF TIME POST RIGHT HIP REVISION. 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
    595242 ARCOS MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 098840

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization