BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 17X190MM SPL TPR DIST HA

    MDR report key: 7082550 · Received December 5, 2017

    Report

    Report Number
    0001825034-2017-10558
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    June 17, 2016
    Report Date
    February 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    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). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-10555. 0001825034-2017-10556. 0001825034-2017-10557. 0001825034-2017-10558. 0001825034-2017-10559. 0001825034 -2017-10560. CONCOMITANT MEDICAL PRODUCTS: ACETABULAR CUP, UNKNOWN PART/LOT; FEMORAL HEAD, UNKNOWN PART/LOT; ACETABULAR LINER, UNKNOWN PART/LOT; UNKNOWN FEMORAL STEM, UNKNOWN PART/LOT; 11-302102 ARCOS TROCH CLAW SMALL 100 MM LOT 085570; 11-302142 ARCOS LATERAL TROCH BOLT 42 MM LOT 398520. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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
    864371 ARCOS 17X190MM SPL TPR DIST HA PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 504230

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R