BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ C STD 70MM

    MDR report key: 11446918 · Received March 9, 2021

    Report

    Report Number
    0001825034-2021-00657
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    January 15, 2021
    Report Date
    March 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304474666
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT MULTIPLE RIGHT HIP REVISION HAVE BEEN PERFORMED SINCE (B)(6) 2019, WITH A KNOWN HISTORY OF PRIOR RIGHT HIP INFECTION. WITH MULTIPLE SURGICAL REVISION TO RIGHT HIP, INCREASES THE PATIENTS RISK TO DEVELOP INFECTIONS. 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, THEREFORE 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 110010271 ¿ G7 MULTIHOLE SHELL - R3713970A; 11-300817 ¿ ARCOS DISTAL STEM ¿ 838140; 30124009 ¿ G7 VIT E HIGH WALL LINER ¿ 64714864; 650-1067 ¿ BIOLOX DELTA TAPER 3031101; 650-1058 ¿ BIOLOX DELTA HEAD - 2993794. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNING FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00479, 0001825034-2021-00499, 0001825034-2021-00480.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A FIRST STAGE REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION, A SECOND STAGE REVISION APPROXIMATELY 2 MONTHS LATER AND 3 MORE SURGERIES WITHIN A 15 MONTH PERIOD OF TIME. SUBSEQUENTLY, THE PATIENT UNDERWENT ANOTHER REVISION APPROXIMATELY 1 MONTH AFTER THE LAST DUE TO INFECTION. 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
    340249 ARCOS CON SZ C STD 70MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 213330 00880304474666

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R SEE H10