BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM BEARING 28X46MM

    MDR report key: 13481301 · Received February 8, 2022

    Report

    Report Number
    0001822565-2022-00379
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 14, 2022
    Report Date
    March 31, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    UDI-DI
    00889024572713
    PMA / PMN Number
    K190656
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#11-301302 ; ARCOS CON SZ B STD 60MM; LOT#360360. CAT#11-300808; ARCOS 18X150MM SPL TPR DIST; LOT#221260. CAT#650-1064; CER OPTION TYPE 1 TPR SLEVE -6; LOT#3032903. CAT#650-1055; CER BIOLOXD OPTION HD 28MM; LOT#3062495. CAT#110024465; G7 DUAL MOBILITY LINER 46MM G; CAT#371300. CAT#00625006535; BONE SCR 6.5X35 SELF-TAP; LOT#J6851898. CAT#00625006535; BONE SCR 6.5X35 SELF-TAP; LOT#J6851905. CAT#110010267; G7 OSSEOTI MULTIHOLE 58MM G; LOT#6512782. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY HOSPITAL; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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 BECAME DISLOCATED AND COULD NOT BE REDUCED THROUGH CLOSED REDUCTION. HAD TO OPEN AND FOUND FEMORAL HEAD BECAME DISASSOCIATED FROM DM POLY LINER. DM CONSTRUCT REMOVED AND FREEDOM CONSTRUCT PUT IN PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904023 VIVACIT-E DM BEARING 28X46MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 65016432 00889024572713

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H