BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD RGX AUG - LG

    MDR report key: 19404209 · Received May 28, 2024

    Report

    Report Number
    0001825034-2024-01367
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    February 6, 2024
    Report Date
    June 13, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K111746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: COMPR SRS PROX BDY - SM 58MM CAT#211216 LOT#NI. COMPR SRS IC SEG - 120MM CAT#211227 LOT#NI. COMPR SRS MOD RGX AUG - LG CAT#211229 LOT#NI. COMPR SRS MOD STEM - 9X75MM CAT#211258 LOT#NI. G2: DENMARK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2024 - 01365 0001825034 - 2024 - 01366 0001825034 - 2024 - 01368

    Description of Event or Problem · 0

    IT WAS REPORTED IN A STUDY THAT A PATIENT REQUIRED MEDICAL INTERVENTION APPROXIMATELY 2 WEEKS POST IMPLANTATION DUE TO INFECTION, WOUND DEHISCENCE, NECROSIS, AND DRAINAGE. THE PATIENT WAS PRESCRIBED VEPICOMBIN AND THE INFECTION WAS CONSIDERED RESOLVED THE FOLLOWING WEEK. ALL IMPLANTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663974 COMPR SRS MOD RGX AUG - LG PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. NI 154430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention