BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUM CENTRED HEAD 48MM

    MDR report key: 7048370 · Received November 21, 2017

    Report

    Report Number
    3006946279-2017-00261
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 25, 2017
    Report Date
    April 30, 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

    (B)(4). CONCLUSION : THE PRODUCTS HAVE BEEN MANUFACTURED ACCORDING PRE-DEFINED SPECIFICATIONS. BASED ON THE LIMITED AVAILABLE DATA, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED DISLOCATION OF THE T.E.S.S.®. THE REPORTED DISLOCATION PRIOR TO THE SECOND REVISION SURGERY COULD BE DUE TO THE ABSENCE OF ONE OF THE SCREW (REMOVED DURING THE 1ST REVISION (2ND SURGERY OF THE PATIENT)) AND/OR THE PATIENT¿S SUBSCAPULARIS TENDON INSUFFICIENCY. PURSUANT TO THE APPLICABLE INSTRUCTIONS FOR USE ¿DISLOCATION OR SUBLUXATION OF THE PROSTHETIC COMPONENTS MAY BE THE RESULT OF INADEQUATE AND/OR INCOMPLETE INSERTION, INCORRECT POSITIONING AND/OR MOVEMENT OF THE COMPONENTS. RELAXATION OF MUSCLE AND FIBROUS TISSUES CAN ALSO CONTRIBUTE TO THESE PHENOMENA. TRAUMA MAY CAUSE LOOSENING OR MIGRATION OF THE PROSTHETIC COMPONENTS¿. ACCORDING TO THE AVAILABLE DATA, THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSION OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 3006946279 - 2017 - 00260, 3006946279 - 2017 - 00261. UDI UNIQUE DEVICE IDENTIFIER (B)(4). CONCOMITANT PRODUCT(S):- P1700485 TESS GLEN INSERT S2 LOT 0000859828. P1700136 TESS HUM CENTRED HEAD 48MM LOT 0001069725. 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. P1700055 TESS GLENOID SCREW 4.5X25 LOT 0001190544. REPORT SOURCE- FOREIGN. THE EVENT OCCURRED IN (B)(6). PMA 510(K): THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET UK AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET UK 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO SHOULDER DISLOCATION. THE PATIENT WAS IMPLANTED WITH A CEMENTLESS GLENOID AND NEW FEMORAL HEAD. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830258 TESS HUM CENTRED HEAD 48MM PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A 0001069725

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R