BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL MOBILITY VIVACIT-E 22.2MM I.D. 36MM O.D. SIZE B BEARING

    MDR report key: 19515135 · Received June 11, 2024

    Report

    Report Number
    0001822565-2024-01961
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    September 19, 2023
    Report Date
    September 16, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572829
    PMA / PMN Number
    K190656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: A1. A2. A3. A4. B4. B5. B7. G3. G6. H2. H10.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 163651 ITEM NAME 22.2MM DIA COCR MOD HD STD NK LOT # 634430; 51-100040 ITEM NAME TPRLC 133 FP TYPE1 PPS SO 4.0 LOT # 6435004. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 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 EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. 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 THERE WAS A HOLE IN THE PACKAGING SO A SECOND SET OF STEM, HEAD, AND DUAL MOBILITY LINER WAS OPENED TO ASSURE SAFETY OF PATIENT. THE PROCEDURE WAS COMPLETED WITH NEW IMPLANTS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A HOLE IN PACKAGE OF FEMORAL STEM FROM THE OFFICE KIT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197488 DUAL MOBILITY VIVACIT-E 22.2MM I.D. 36MM O.D. SIZE B BEARING PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 65619275 00889024572829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female