BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 16X250MM INTLKNG DIST

    MDR report key: 18020352 · Received October 27, 2023

    Report

    Report Number
    0001825034-2023-02501
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    October 2, 2023
    Report Date
    January 31, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304475212
    PMA / PMN Number
    K100469
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED 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

    (B)(4). D10: 11-301342 ITEM NAME ARCOS CON SZ B STD 80MM LOT # 250770. CP250311 ITEM NAME 5.0MMX30MM TI KAESSMANN SCREW LOT# 668120. CP250312 ITEM NAME 5.0MMX35MM TI KAESSMANN SCREW LOT# 668150. 11-302128 ITEM NAME ARCOS LATERAL TROCH BOLT 28MM LOT # 718130. 11-363660 ITEM NAME 36MM COCR MOD HD - 6MM LOT# J7430617 . G2: FOREIGN: NEW ZEALAND. 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

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ONE WEEK POST IMPLANTATION DUE TO AN INFECTION AND STEM LOOSENING. IT IS BELIEVED THAT THE STEM LOOSENED DUE TO BECOMING FRACTURED. SAMPLES WERE TAKEN AT THE TIME OF INITIAL SURGERY SHOWED POSITIVE FOR AN INFECTION. THERE IS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023520 ARCOS 16X250MM INTLKNG DIST PROSTHETIC, HIP KWA ZIMMER BIOMET, INC. N/A 445610 00880304475212

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H PLEASE SEE H10.