BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUM INSERT TH 8 DIA36 S0

    MDR report key: 6558676 · Received May 10, 2017

    Report

    Report Number
    3006946279-2017-00093
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    April 10, 2017
    Report Date
    May 8, 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

    (B)(6). MEDICAL PRODUCT - TESS HUM REVERSE COROLLA S0, CAT#: P1700430 LOT#: 0001169114. THIS DEVICE IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K060694. PRODUCT IS CURRENTLY NOT EXPECTED TO RETURN TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006946279-2017-00092 AND 3006946279-2017-00093.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY, IT WAS NOT POSSIBLE TO INSERT THE 6 MM HUMERAL INLAY INTO THE REVERSE COROLLA. AFTER SEVERAL IMPACTION ATTEMPTS, THE COROLLA MIGRATED. A SECOND, THICKER HUMERAL INLAY WAS IMPACTED, AND ALSO COULD NOT BE SEATED. DURING IMPACTION, THE HUMERUS FRACTURED. THE 8 MM BEARING WAS EVENTUALLY ABLE TO BE SEATED INTO THE COROLLA AND A CABLE WIRE WAS UTILIZED TO FIX THE FRACTURE AND PROSTHESIS INTO PLACE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339131 TESS HUM INSERT TH 8 DIA36 S0 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0001196572

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention