BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X46MM

    MDR report key: 16195427 · Received January 18, 2023

    Report

    Report Number
    0001825034-2023-00092
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 20, 2022
    Report Date
    April 11, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485058
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A RADIOGRAPH WAS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. AS THE COMPLAINT IS INFECTION RELATED THE X-RAY DID NOT ENHANCE THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. NO DEVICE PROBLEM WAS FOUND. 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). CONCOMITANT MEDICAL PRODUCTS: 650-1064 ¿ CERAMIC TAPER ¿ 3064989. 650-1055 ¿ CERAMIC HEAD ¿ 2020011173. 47249009700 ¿ TEAR DROP GUIDE WIRE ¿ 65316177. 166069 ¿ ARCOS SCREW ¿ 6828663. 166069 ¿ ARCOS SCREW ¿ 7032015. 166070 ¿ ARCOS SCREW ¿ 6970413. 166068 ¿ ARCOS SCREW ¿ 7053131. 166067 ¿ ARCOS SCREW ¿ 7197916. REPORT SOURCE AUSTRALIA. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION AS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 00091, 0001825034 - 2023 - 00093, 0001825034 - 2023 - 00094, 0001825034 - 2023 - 00095, 0001825034 - 2023 - 00096, 0001825034 - 2023 - 00097, 0001825034 - 2023 - 00098.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A FIRST STAGE REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO A BACTERIAL INFECTION. ALL COMPONENTS WERE REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923710 ACT ARTIC E1 HIP BRG 28X46MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 930800 00880304485058

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R