BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 75MM

    MDR report key: 20075110 · Received August 27, 2024

    Report

    Report Number
    0001825034-2024-02087
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    August 7, 2024
    Report Date
    March 25, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10- MEDICAL PRODUCT. REFOBACIN PLUS BONE CEMENT 40 ITEM# 3020830401 LOT# A414AF2405. VANGUARD CR FEM 72.5 RT-MACH ITEM# 183013-01 LOT# 760550. SERIES A PAT W/WR STD 31 1 PEG ITEM# 184704 LOT# 651580. SVC-VNGD CR LIP TIB BRG ITEM# 183544CLPK LOT# 357300. G2- AUSTRALIA H3- 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D2, D4, G1, G3, G6, H1, H2, H3, H6, AND H11. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INITIAL SURGICAL NOTES REVIEWED: NO COMPLICATIONS NOTED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LOOSENING AND MEDIAL SUBSIDENCE OF THE TIBIAL IMPLANT OF THE RIGHT KNEE ARTHROPLASTY WITH RESULTING VARUS MALALIGNMENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS CONFIRMED WITH THE RADIOGRAPHS PROVIDED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE.TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY NINE YEARS AND FIVE MONTHS POST IMPLANTATION DUE TO ASEPTIC LOOSENING OF THE TIBIA RESULTING IN VARUS COLLAPSE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23582 POLISHED FINNED TIB TRAY 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 2014071637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H