BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS GLEN INSERT S2

    MDR report key: 7048354 · Received November 21, 2017

    Report

    Report Number
    3006946279-2017-00259
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    May 22, 2017
    Report Date
    January 25, 2018
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    (B)(4). UDI # (B)(4). CONCOMITANT MEDICAL PRODUCTS: P1700332 TESS GLENOID CMTLESS BSEPLT S2, LOT # 0001141097. P1700004 TESS GLEN HUM SCREW 4.5X30, LOT#0001174143. P1700004 TESS GLEN HUM SCREW 4.5X30, LOT#0001164126. P1700136 TESS HUM CENTRED HEAD 48MM, LOT# 0001069725. P1700446 TESS HUM ANATOMICAL COROLLA S3, LOT#0001142834. P1700128 TESS HUM STEM SMALL, LOT#0001160372 REPORT SOURCE- FOREIGN. THE EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K060694. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS DISLOCATION OF THE RIGHT GLENOID SHOULDER COMPONENT. IT WAS IDENTIFIED THE SUBSCAPULARIS TENDON RUPTURED WITH LOW RETRACTION. THE LINER AND THE UPPER SCREW WAS REMOVED. ONLY THE LINER WAS REPLACED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830102 TESS GLEN INSERT S2 PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0000813784

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R