BEUDAMED
    FDA Adverse Event Injury Summary report: N

    #7 PE 50IN ZPLP EXT TOGGLELOC

    MDR report key: 21210719 · Received January 22, 2025

    Report

    Report Number
    0001825034-2025-00189
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    September 30, 2022
    Report Date
    April 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00880304464858
    PMA / PMN Number
    K130033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: COMPOSITCP 60 11X30MM INT SCR CAT# 905263 LOT# 195056. ANTERIOR TIBIALIS FZ ASP CAT# (B)(6) SERIAL# (B)(6). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO ASEPTIC FUNGAL INFECTION, SEVERE PAIN AND AMBULATION DIFFICULTY. THE PATIENT WAS EXPERIENCING CHILLS, NIGHT SWEATS, FEVER, AND KNEE PAIN IMMEDIATELY AFTER THE INITIAL PROCEDURE AND THIS CONTINUED UNTIL THE REVISION OCCURRED WHERE AN ACL GRAFT AND THE HARDWARE WAS REMOVED. THE PATIENT HAS CONTINUED TO HAVE PAIN AND MOBILITY ISSUES AND AN ADDITIONAL PROCEDURE TO REMOVE FUNGAL GROWTH OCCURRED APPROXIMATELY 5 MONTHS POST OP.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
    589083 #7 PE 50IN ZPLP EXT TOGGLELOC TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE MBI ZIMMER BIOMET, INC. P13205 00880304464858

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Hospitalization| R SEE H11