BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 79MM

    MDR report key: 22171370 · Received June 9, 2025

    Report

    Report Number
    0001825034-2025-01650
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 5, 2025
    Report Date
    November 4, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00887868558696
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: UPDATED: B4, B5, G3, G6, H1, H2, H3, H4, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF STERILE CERTS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. FEMORAL, TIBIA AND ARTICULAR SURFACE ARE COMPATIBLE WITH EACH OTHER HOWEVER ENTIRE CONSTRUCT COMPATIBILITY CANNOT BE ASSESSED. MEDICAL RECORDS WERE NOT PROVIDED. 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. THE EVENT IS NOT CONFIRMED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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). G2: ITALY. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. D10: ADDITIONAL ASSOCIATED PRODUCTS: 183210 VANGUARD PS CLSD INTLK FEM-RT 67.5, LOT# B66972957. 183760 VANGUARD PS+ TIB BRG 10X79/83MM, LOT# J7704961. UNK PATELLA, LOT# UNK.

    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 THE PATIENT UNDERWENT REVISION SURGERY DUE TO AN UNSPECIFIED INFECTION IN THE RIGHT KNEE APPROXIMATELY ONE MONTH POST IMPLANTATION. ALL IMPLANTS WERE REMOVED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632447 BIOMET CC CRUCIATE TRAY 79MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. J7871699 00887868558696

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Unknown Hospitalization| R SEE H11 NARRATIVE