BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ARCOS DISTAL STEM

    MDR report key: 16195449 · Received January 18, 2023

    Report

    Report Number
    0001825034-2023-00098
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 20, 2022
    Report Date
    April 11, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: COMPONENT CODE: MECHANICAL (G04) ¿ STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A RADIOGRAPH WAS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. AS THE COMPLAINT IS INFECTION RELATED THE X-RAY DID NOT ENHANCE THE INVESTIGATION. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1064 ¿ CERAMIC TAPER ¿ 3064989, 650-1055 ¿ CERAMIC HEAD ¿ 2020011173, 47249009700 ¿ TEAR DROP GUIDE WIRE ¿ 65316177, 166069 ¿ ARCOS SCREW ¿ 6828663, 166069 ¿ ARCOS SCREW ¿ 7032015, 166070 ¿ ARCOS SCREW ¿ 6970413, 166068 ¿ ARCOS SCREW ¿ 7053131, 166067 ¿ ARCOS SCREW ¿ 7197916. REPORT SOURCE: AUSTRALIA. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION AS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 00091, 0001825034 - 2023 - 00092, 0001825034 - 2023 - 00093, 0001825034 - 2023 - 00094, 0001825034 - 2023 - 00095, 0001825034 - 2023 - 00096, 0001825034 - 2023 - 00097.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A FIRST STAGE REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO A BACTERIAL INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED. 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
    924715 UNKNOWN ARCOS DISTAL STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10.