BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM BEARING 28X42MM

    MDR report key: 17631655 · Received August 28, 2023

    Report

    Report Number
    0001822565-2023-02265
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    January 11, 2023
    Report Date
    October 25, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572690
    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 FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4 G3 G6 H2 H6 H10 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT THA WAS PERFORMED WITH COMPETITOR PRODUCTS AND THE PATIENT HAS A HISTORY OF RA AND SCOLIOSIS. A REVISION OCCURRED LATER ON DUE TO RECURRENT DISLOCATIONS, WHERE A MIX OF ZB AND COMPETITOR PRODUCTS WERE IMPLANTED. A FEW MONTHS LATER, THE PATIENT BENT OVER AND DISLOCATED AGAIN, WITH ANOTHER REVISION. THE SHELL AND STEM REMAINED AND A STRYKER CONSTRAINED LINER AND ZB CERAMIC HEAD WERE PLACED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS UNKNOWN IF THE OFF LABEL USE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 · 0

    (B)(4). D10: 00877502802 ITEM NAME BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14 LOT # 3101747. 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 H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO RECURRENT DISLOCATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338892 VIVACIT-E DM BEARING 28X42MM PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 65233779 00889024572690

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H PLEASE SEE H10.