BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACC COCR CBL 2.0 W/CLMP SAMPLE

    MDR report key: 9411303 · Received December 4, 2019

    Report

    Report Number
    1020279-2019-04281
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    October 24, 2019
    Report Date
    July 15, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UPON POST-OPERATIVE VISIT, A BROKEN ACCORD WAS FOUND. NO INJURIES OR DELAYS REPORTED. BACKUP DEVICE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204438 ACC COCR CBL 2.0 W/CLMP SAMPLE PROSTHSIS, KNE, PATLLOFMOROTIBIAL, SMI-CONSTRAIND, CM NTD, POLYMR/MTL JWH SMITH & NEPHEW, INC. 19FSM0683

    Patients

    Seq Age Sex Outcome Treatment
    1