BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANAT BRG LT MD SIZE 3 PMA

    MDR report key: 19123848 · Received April 17, 2024

    Report

    Report Number
    3002806535-2024-00148
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    March 11, 2024
    Report Date
    August 30, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    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

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: UNKNOWN OXFORD CEMENTLESS TIBIAL COMPONENT; ITEM# UNKNOWN; LOT# UNKNOWN. UNKNOWN OXFORD CEMENTLESS FEMORAL COMPONENT; ITEM# UNKNOWN; LOT# UNKNOWN. G2 - FOREIGN: UNITED KINGDOM. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D1, D4, D9, D10, G3, G6, H1, H2, H3, H4, H6, H11. D10 - ASSOCIATED MEDICAL DEVICES: 166576 OXF UNI CMNTLS TIB SZ D LM LOT # 3253256. 154926 OXFORD PH3 CEMENTLESS FEM SZ M LOT # 3207661. THE PRODUCTS WERE RETURNED AND THE BEARING WAS VISUALLY EVALUATED. IT EXHIBITS SIGNS OF USE (NICKED, GOUGED, DISCOLORATION) AND CONFIRMS THE COMPLAINT IN THAT IT HAS SIGNIFICANT WEAR. DUE TO EXCESSIVE WEAR TO BOTTOM NO MEASUREMENTS HAVE BEEN TAKEN. THE BEARING HAS POTENTIALLY BEEN IMPLANTED FOR UP TO TEN YEARS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO WEAR OF THE OXFORD BEARING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    1063404 OXFORD ANAT BRG LT MD SIZE 3 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 3255061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H SEE H11 NARRATIVE