BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD FIXED LATERAL BRG E5

    MDR report key: 10355800 · Received August 3, 2020

    Report

    Report Number
    0001825034-2020-02861
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    November 12, 2019
    Report Date
    August 6, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. IT IS NOW VERIFIED THAT THIS DEVICE IS NOT RELATED TO THE EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. IT IS NOW VERIFIED THAT THIS DEVICE IS NOT RELATED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA EM MED CATALOG # 161469, LOT # 2807475. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO MEDICAL PROGRESSIVE ARTHRITIS. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824539 OXFORD FIXED LATERAL BRG E5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 030220

    Patients

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