BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ A STD 70MM HA

    MDR report key: 7285312 · Received February 21, 2018

    Report

    Report Number
    0001822565-2018-01053
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    June 17, 2016
    Report Date
    February 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PT-106056 REGEN/RNGLC+ MULTI 56MM SZ 24 360640 163670 32MM MOD HEAD COCR +3MM NECK 00J3235778, 22-300917 ARCOS 17X190MM SPL TPR DIST HA 504230, 11-302102 ARCOS TROCH CLAW SMALL 100MM 085570, 11-302142 ARCOS LATERAL TROCH BOLT 42MM 398520, 22-301321 ARCOS CON SZ A STD 70MM HA 013730, UNK SCREW, EP053254 RINGLOC-X E1 H/W 54/32MM 24 3276013. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S., HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K090757.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INCISION AND DRAINAGE APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO SUBCUTANEOUS ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129337 ARCOS CON SZ A STD 70MM HA HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 013730

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention| S