BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII ARTICULAR INSERTER/EXTRACT

    MDR report key: 7260844 · Received February 9, 2018

    Report

    Report Number
    1020279-2018-00140
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    November 16, 2017
    Report Date
    June 13, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBH
    UDI-DI
    03596010214393
    PMA / PMN Number
    K121393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K'S ASSOCIATED WITH IMPLANTED DEVICES: K951987, K032295, K060742.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED GENESIS II ARTICULAR INSERTER/EXTRACTOR CONFIRMS THE STATED FAILURE. THE INSTRUMENT IS FRACTURED AT THE LOCATION OF THE HOOK FEATURE ON THE HANDLE. IT IS LIKELY THAT THE FRACTURE WAS DUE TO AN OVERLOAD MECHANISM. AN OVERLOAD FRACTURE CAN OCCUR IF MECHANICAL LOADS ARE APPLIED THAT EXCEED THE STRENGTH OF THE MATERIAL. MANUFACTURED IN 2014, THIS INSTRUMENT EXHIBITS SIGNS OF REPEATED USE AND SIGNIFICANT WEAR. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ANY PREVIOUS COMPLAINTS FOR THE LISTED BATCH. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. NO RELEVANT CLINICAL DOCUMENTS WERE PROVIDED. IF ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE INSTRUMENT BROKE DURING SURGERY AND WAS LEFT IN THE PATIENT. THE PATIENT HAD TO RETURN FOR AN ADDITIONAL SURGERY TO REMOVE THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103912 GII ARTICULAR INSERTER/EXTRACT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED MBH SMITH & NEPHEW, INC. 14DM20420 03596010214393

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R GENESIS II INSERT 71421508/17ET86698| GENESIS II TIBIA SHAFT 76547001/17ET87972| GENESIS II TIBIAL BASE 71420166/G1708700| LEGION FEMORAL COMPONENT 71423225/17EM10411