BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 66MM I

    MDR report key: 11330400 · Received February 15, 2021

    Report

    Report Number
    0001825034-2021-00479
    Event Type
    Injury
    Date Received
    February 15, 2021
    Date of Event
    January 15, 2021
    Report Date
    March 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    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 JUNE 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.

    Additional Manufacturer Narrative · 0

    D10: 11-301323 ¿ ARCOS CONE ¿ 213330 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A FIRST STAGE REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST INITIAL RIGHT TOTAL HIP ARTHROPLASTY AND A SECOND STAGE APPROXIMATELY 2 YEARS LATER. SUBSEQUENTLY, THE PATIENT UNDERWENT 3 ADDITIONAL SURGERIES WITHIN A 15 MONTH TIME FRAME. THE PATIENT UNDERWENT ANOTHER REVISION APPROXIMATELY 1 MONTH LATER DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 650-1067 CER OPTION TYPE 1 TPR SLEEVE +3 LOT# 3031101, CAT# 30124009 G7 VIT E HIGH WALL LNR 40MM I LOT#64714864, CAT# 650-1058 CER BIOLOXD OPTION HD 40MM LOT# 2993794, CAT#11-300817 ARCOS 17X150MM SPL TPR DIST LOT#838140. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2021-00476, 0001825034-2021-00480, 0001825034-2021-00499.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 11 MONTHS POST IMPLANTATION DUE TO AN INFECTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223343 G7 OSSEOTI MULTIHOLE 66MM I PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A R3713970A

    Patients

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