BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUMERAL INSERT TH 6 DIA36 S1

    MDR report key: 6061156 · Received October 27, 2016

    Report

    Report Number
    3006946279-2016-00402
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    January 2, 2013
    Report Date
    April 20, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET 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. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 3006946279-2016-00402 / 00403).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A SHOULDER REVISION DUE TO DISLOCATION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711931 TESS HUMERAL INSERT TH 6 DIA36 S1 PROSTHESIS, HIP KWS BIOMET FRANCE S.A.R.L. N/A 0000717359

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R