BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM LINER 28 X 46MM

    MDR report key: 11068213 · Received December 23, 2020

    Report

    Report Number
    0001822565-2020-04214
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    December 2, 2020
    Report Date
    April 13, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190656
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED, TO RELAY ADDITIONAL INFORMATION. VISUAL EVALUATION OF THE PROVIDED INTRAOPERATIVE PHOTO IDENTIFIED, THAT THE BEARING WAS DISASSOCIATED FROM THE HEAD. VISUAL EVALUATION OF THE RETURNED HEAD AND BEARING WERE ASSEMBLED AND IDENTIFIED DAMAGE ON THE RIM FEATURE, AND THE OUTER SPHERICAL SURFACE OF THE LINER. DHR WAS REVIEWED, AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS UNABLE TO 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE, AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1055 ¿ CERAMIC HEAD ¿ 2964312. 650-1068 ¿ CERAMIC TAPER SLEEVE ¿ 2959203. UNKNOWN CUP ¿ UNKNOWN PART AND LOT. UNKNOWN STEM ¿ UNKNOWN PART AND LOT. PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY 3 WEEKS LATER DUE TO DISASSOCIATION OF THE HEAD FROM THE BEARING. THE HEAD AND BEARING WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT. 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
    1528446 VIVACIT-E DM LINER 28 X 46MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64782702

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10