BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM BEARING 28X50MM

    MDR report key: 12627931 · Received October 13, 2021

    Report

    Report Number
    0001822565-2021-02978
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    September 20, 2021
    Report Date
    November 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572737
    PMA / PMN Number
    K190656
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE EVENT WAS CONFIRMED WITH MEDICAL RECORDS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED A REVISION OCCURRED DUE TO INSTABILITY AND DISLOCATION. THE SHELL WAS FOUND TO BE LOOSE IN THE JOINT. A NEW HEAD, LINER, TAPER SLEEVE, AND SCREWS WERE IMPLANTED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 5 DAYS POST IMPLANTATION DUE TO DISLOCATION. DURING THE REVISION THE ACETABULAR SHELL WAS IN A DIFFERENT POSITION FROM PREVIOUS SURGERY. THE SHELL, LINER, BEARING, SLEEVE, AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: CATALOG#: 110024466 G7 DUAL MOBILITY LINER 50MM H LOT#: 755990; CATALOG#: 110010250 G7 OSSEOTI 4 HOLE SHELL 64MM H LOT#: 6459948; CATALOG#: 650-1068 CER OPTION TYPE 1 TPR SLEVE +6 LOT#: 2900905; CATALOG#: 650-1055 CER BIOLOXD OPTION HD 28MM LOT#: 3050674. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO HOSPITAL POLICY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02852, 0001825034-2021-02853.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INSTABILITY AND DISLOCATION. 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
    1523599 VIVACIT-E DM BEARING 28X50MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64731446 00889024572737

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R