BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 22X150MM SPL TPR DIST

    MDR report key: 7751364 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05518
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    November 9, 2016
    Report Date
    September 11, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : BIOMET ARCOS MODULAR REVISION SYSTEM CONE PROXIMAL BODY / TYPE I TAPER SIZE C STANDARD OFFSET 60MM CATALOG #: 11-301303 LOT #: 921390, ZIMMER CONTINUUM TRABECULAR METAL CUP 56MM CATALOG #: NI LOT #: NI, ZIMMER LONGEVITY NEUTRAL LINER CATALOG #: NI LOT #: NI, BIOMET BIOLOX-DELTA CERAMIC HEAD TYPE 16/18 TAPER WITH TYPE I OPTION TAPER ADAPTER 40MM CATALOG #: 650-1058 LOT #: NI, BIOMET CERAMIC OPTION TYPE 1 TAPERED SLEEVE CATALOG #: 650-1067 LOT #: NI. THE COMPLAINT SAMPLE WAS NOT EVALUATED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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). CONCOMITANT MEDICAL PRODUCTS: ARCOS CON SZ C STD 60MM, PN 11-301303 LN 921390. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-05517. 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 MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED TROCHANTERIC BURSITIS APPROXIMATELY THREE YEARS POST-IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592965 ARCOS 22X150MM SPL TPR DIST PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 342790

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other