BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESS HUM INSERT TH 6 DIA36 S0

    MDR report key: 6558559 · Received May 10, 2017

    Report

    Report Number
    3006946279-2017-00092
    Event Type
    Malfunction
    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
    PK060694
    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. 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
    340134 TESS HUM INSERT TH 6 DIA36 S0 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0001172381

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention