BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM MD PMA

    MDR report key: 15842907 · Received November 22, 2022

    Report

    Report Number
    3002806535-2022-00470
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 31, 2022
    Report Date
    January 3, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279438242
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF UNI TIB TRAY SZ C RM PMA ITEM#154723 LOT#2800104; OXF ANAT BRG RT MD SIZE 3 PMA ITEM#159575 LOT#2944793. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2022-00472; 3002806535-2022-00473.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED BUT WERE OF POOR QUALITY AND UNCLEAR DATES THEREFORE OF NO VALUE TO THIS INVESTIGATION. THE MEDICAL RECORDS PROVIDED WERE REVIEWED STATING THE PATIENT IS OVERWEIGHT BUT CONTAIN NO FURTHER INFORMATION THAT WOULD ENHANCE THIS INVESTIGATION. A DEFINITIVE ROOT CAUSE CANNOT 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 DUE TO PAIN, APPROXIMATELY NINE (9) YEARS THREE (3) MONTHS AFTER INITIAL SURGERY. TOTAL KNEE CONVERSION WAS PERFORMED DURING THE REVISION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    2688261 OXF TWIN-PEG CMNTD FEM MD PMA KNEE PROTHESIS NRA BIOMET UK LTD. N/A 2920019 05019279438242

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE.