BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM VIVACIT-E POLY LINER

    MDR report key: 6152722 · Received December 7, 2016

    Report

    Report Number
    0001822565-2016-04567
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 21, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK091508
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), ZIMMER ACETABULAR CUP, LOT #62861098; ITEM # 0001822565-2016-04567, FITMORE FEMORAL STEM, LOT #2781716.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA DOCTOR'S OFFICE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATENT'S HIP DISLOCATED WHILE DOING YOGA. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT TO HAVE THE HIP RELOCATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT HIP DISLOCATION, PAIN AND POPPING WITH BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803663 CONTINUUM VIVACIT-E POLY LINER PROSTHESIS, HIP LZO ZIMMER, INC. N/A 62838260

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention