BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT MD SIZE 3 PMA

    MDR report key: 19738733 · Received July 15, 2024

    Report

    Report Number
    3002806535-2024-00261
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 23, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786213
    PMA / PMN Number
    P010014
    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: ITEM#166942; LOT#3249248; OXFORD UNI TWIN-PEG FEMORAL MD. ITEM#154725; LOT#3010978; OXF UNI TIB TRAY SZ D RM PMA. G2- AUSTRALIA. 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE BEARING HAD FRACTURED INTO TWO PIECES AND EXHIBITED SIGNS OF WEAR, MINOR PITTING AND GOUGES ON THE BEARING SURFACE THAT IS TYPICAL WITH INVITRO USE. THE ITEM HAS BEEN IN IMPLANTED FOR APPROXIMATELY 9 YEARS AND 6 MONTHS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. 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 REVISION SURGERY DUE TO A BEARING FRACTURE, APPROXIMATELY 9 YEARS AND 6 MONTHS POST-IMPLANTATION. A NEW BEARING WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    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
    1392227 OXF ANAT BRG RT MD SIZE 3 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 3427892 05019279786213

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R