BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC DA2000 KN TIB BRG 79/83X10

    MDR report key: 19259351 · Received May 7, 2024

    Report

    Report Number
    3002806535-2024-00166
    Event Type
    Injury
    Date Received
    May 7, 2024
    Report Date
    June 7, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    UDI-DI
    05019279389568
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: AGC DA 2000 FEMORAL RIGHT 75MM; ITEM# 154809; LOT# 804579; AGC DA 2000 TIBIAL TRAY 79MM; ITEM# 154815; LOT# 1328893; BMT SPLINED KNEE STM 20X80; ITEM# 141620; LOT# 465720; BMT SPLINED KNEE STM 24X80; ITEM# 141624; LOT# 588930; BMET ARCOM AP PATELLA 34MM; ITEM# 11-150822; LOT# 1161262. G2 - FOREIGN: UNITED KINGDOM. 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.

    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 DUE TO BEARING WEAR, THE PATIENT IS PLANNED TO UNDERGO A REVISION. THE SURGEON IS CURRENTLY AWAITING CUSTOM IMPLANTS FOR THE PATIENT, A DATE FOR THE REVISION HAS NOT BEEN DETERMINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671662 AGC DA2000 KN TIB BRG 79/83X10 KNEE PROSTHESIS JWH BIOMET UK LTD. 1225563 05019279389568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11 NARRATIVE.