BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUMERAL INSERT TH 6 DIA36 S0

    MDR report key: 6276164 · Received January 25, 2017

    Report

    Report Number
    3006946279-2017-00020
    Event Type
    Injury
    Date Received
    January 25, 2017
    Date of Event
    February 17, 2016
    Report Date
    January 25, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. VISUAL INSPECTION SHOWED THAT THE TWO RINGS LOCK ARE DAMAGED. THIS DAMAGE MOST LIKELY OCCURRED DURING THE SURGICAL PROCEDURE, WHEN THE SURGEON TRIED TO IMPACT THE INSERT IN THE REVERSE COROLLA. EXAMINATION OF THE INSERT REVEALS DAMAGE. THE INSERT MAY HAVE BEEN IN THE WRONG POSITION DURING THE IMPACTION PROCEDURE. THE SURGEON MAY HAVE ATTEMPTED TO FORCE IMPACTION OF THE INSERT INTO THE REVERSE COROLLA. THERE IS NO ELEMENT WHICH COULD JEOPARDIZE THE CONFORMITY OF THE PRODUCTS. A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS MOST LIKELY MALPOSITIONING OF THE INSERT DURING IMPACTION OR FORCEFUL IMPACTION INTO THE COROLLA. (B)(4). THIS DEVICE IS NOT MANUFACTURED BY (B)(4) IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K060694. (B)(4).

    Description of Event or Problem · 1

    DURING A SHOULDER ARTHROPLASTY, THE INSERT WOULD NOT SEAT IN THE COROLLA. THE COROLLA WAS REPLACED AND ANOTHER INSERT SEATED. THIS RESULTED IN A 1 HOUR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58605 TESS HUMERAL INSERT TH 6 DIA36 S0 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0001064011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention