BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT LG SIZE 3 PMA

    MDR report key: 21975963 · Received May 7, 2025

    Report

    Report Number
    3002806535-2025-00181
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    June 1, 2023
    Report Date
    July 23, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786282
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNKNOWN OXF FEMORAL COMPONENT; ITEM NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN. UNKNOWN OXF TIBIAL COMPONENT; ITEM NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN. G2: FOREIGN, CANADA. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION 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 AND THE REPORTED PART AND LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. FURTHERMORE, BASED OFF OF THE DESCRIPTION IT ISN'T CLEAR IF THE REPORTED COMPLAINT IS ACCURATE. MEDIAL BEARING HOWEVER THE DESCRIPTION STATES THAT THE REVISION INVOLVED THE EXCHANGE OF THE RIGHT LATERAL FEMORAL-TIBIAL BEARING. FURTHERMORE, THE REFERENCE TO E3 IN THE DESCRIPTION IS A SIZE REFERENCE OF FIXED LATERAL - WHICH IS A LATERAL TIBIA/BEARING CONSTRUCT THAT USES A ONE-PIECE OVERMOULDED DESIGN OF BIOMET ORTHOPEDICS LLC. HOWEVER, AS THERE IS NO FURTHER INFORMATION AVAILABLE ACCORDING TO THE DILIGENCE, THIS CANNOT BE EXPLORED FURTHER. 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 KNEE REVISION SURGERY DUE TO THE FRACTURE OF THE BEARING. THE REVISION INVOLVED THE EXCHANGE OF THE RIGHT LATERAL FEMORAL-TIBIAL BEARING. APPROXIMATELY 7 YEARS AND 5 MONTHS POST-IMPLANTATION. 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
    1872869 OXF ANAT BRG RT LG SIZE 3 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. 3631796 05019279786282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H10 NARRATIVE.