BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII PRIM FLEX-EXTEN SPACER BLK

    MDR report key: 8929016 · Received August 26, 2019

    Report

    Report Number
    1020279-2019-03163
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 12, 2019
    Report Date
    September 9, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010469656
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THE DEVICE DID NOT BROKE OVER THE PATIENT INCISION, THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, SURGEON BROKE THE LITTLE WHITE RINGS ON THE BACK TABLE TRYING TO INSERT ADDITIONAL SPACERS. S&N BACKUP DEVICE AVAILABLE. NO DELAY. NO IMPACT OR INJURY TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723575 GII PRIM FLEX-EXTEN SPACER BLK PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. 06HM08246 03596010469656

    Patients

    Seq Age Sex Outcome Treatment
    1