BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANT

    MDR report key: 16930242 · Received May 15, 2023

    Report

    Report Number
    0001825034-2023-01052
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    May 3, 2023
    Report Date
    July 7, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. UNABLE TO CONFIRM COMPLAINT, PART/LOT UNKNOWN AND NO MEDICAL RECORDS PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 650-1055 CER BIOLOXD OPTION HD 28MM 3120162; 110031017 VIVACIT-E DM BEARING 28X54MM 65369911; 650-1065 CER OPTION TYPE 1 TPR SLEVE -3 3137043; 11-300817 ARCOS 17X150MM SPL TPR DIST 122710; 00-6250-065-35 TRILOGY BONE SCR 6.5X35 65847193; 110010251 G7 OSSEOTI 4 HOLE SHELL 6530909. 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, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 5 DAYS POST-IMPLANTATION DUE TO AN INFECTION OF AN UNKNOWN IMPLANT. A CEMENT SPACER WAS PLACED TO TREAT THE INFECTION AFTER IMPLANT REMOVAL. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE 5 DAYS POST-IMPLANTATION DUE TO AN INFECTION OF AN UNKNOWN CEMENT SPACER. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE 5 DAYS POST-IMPLANTATION DUE TO A DISLOCATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475313 UNKNOWN IMPLANT PROSTHETIC, HIP KWY ZIMMER BIOMET, INC. N/A 069510R
    956375 UNKNOWN IMPLANT PROSTHETIC, HIP KWY ZIMMER BIOMET, INC. N/A 069510R

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| R