BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS HIGH FLEX TWIN PEG CEMENTED FEMUR MEDIUM

    MDR report key: 14849596 · Received June 29, 2022

    Report

    Report Number
    3002806535-2022-00288
    Event Type
    Injury
    Date Received
    June 29, 2022
    Report Date
    July 21, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    00887868354854
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF ANAT BRG LT MD SIZE 3 PMA ITEM#159547 LOT#6483393, OXF UNI CMNTLS TIB SZ C LM ITEM#166574 LOT#3922603, PALACOS R+G 2X40G ITEM #66017569 LOT #92804884. REPORT SOURCE: (B)(6). 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 ¿ 00286, 3002806535 - 2022 ¿ 00287.

    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 TO CONFIRM REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORD (DHR 166942 LO# J6466714) IDENTIFIED NO DEVIATIONS DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY AND APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION IS STILL EXPERIENCING PAIN AND INSTABILITY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION 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
    1813314 OXFORD PKS HIGH FLEX TWIN PEG CEMENTED FEMUR MEDIUM KNEE PROSTHESIS NRA BIOMET UK LTD. N/A J6466714 00887868354854

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10 NARRATIVE