BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS GLENOID REVERSE HEAD 41MM

    MDR report key: 11634394 · Received April 8, 2021

    Report

    Report Number
    3006946279-2021-00058
    Event Type
    Injury
    Date Received
    April 8, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    PHX
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCTS TESS GLEN REVERSE HEAD 41MM AND TESS GLENOID CEMENTLESS BASEPLATE S2 WERE RETURNED AND LAB ANALYSIS WAS PERFORMED. THE PRODUCT ANALYSIS SHOWS THAT THE RETURNED PRODUCTS WERE A TESS GLEN REVERSE HEAD 41MM AND TESS GLENOID CEMENTLESS BASEPLATE S2 .THE PRODUCTS HAVE BEEN CHECKED, ALL THE PARTS WERE WELL SCREWED AND WERE NOT DAMAGED. THE REPORTED EVENT WAS NOT CONFIRMED. ONE EXPLANATION COULD BE THAT THE SURGEON PROPERLY PLACED THE HEAD IN THE BASEPLATE BEFORE SENDING THE PRODUCTS BACK FOR ANALYSIS. A COMPLAINT EXTRACT WAS DONE REGARDING REVISION DUE TO DISLOCATION: - 2 COMPLAINTS (2 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON TESS GLEN REVERSE HEAD 41MM, REFERENCE (B)(4), FROM (B)(6)2018 TO (B)(6) 2021. INVESTIGATION RESULTS CONCLUDED THAT THE PRODUCT IS CONFORM AND THE ROOT CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD HIS FIRST SURGERY SEVERAL YEARS AGO FOR A TESS ANATOMIC (WITH A CEMENTED GLENOID). THE PATIENT WAS REVISED FOR A GLENOID LOOSENING, WITH A TESS REVERSED (REPORTED IN (B)(4)). THE PATIENT WAS DOING VERY WELL POSTOPERATIVELY, BUT FELT A SUDDEN PAIN ONE DAY, SEVERAL WEEKS POST OP, AND IT APPEARED THAT THE GLENOSPHERE (TESS REVERSE HEAD) WAS DISSOCIATED FROM THE BASEPLATE, AND THE PATIENT WAS REVISED AGAIN (REPORTED IN (B)(4)). THE TESS REVERSE HEAD WAS REMOVED AND THE BASEPLATE REMAINED IMPLANTED IN THE PATIENT. DURING THE SURGERY, THE SURGEON PAID SPECIFIC ATTENTION TO THE STABILITY OF THE NEW TESS REVERSE HEAD AS THIS WAS THE GOAL OF THE REVISION. UNFORTUNATELY, THE SAME PATIENT EXPERIENCED AGAIN A GLENOSPHERE DISASSEMBLY (TESS REVERSE HEAD) AFTER THIS REVISION. A REVISION WAS PERFORMED AND BOTH THE TESS REVERSE HEAD AND THE BASEPLATE WERE REVISED. THE BASEPLATE REMAINED IMPLANTED IN THE PATIENT AND WAS REMOVED DURING THE NEXT SURGERY. HOWEVER, AS IT WAS INITIALLY ASSESSED THAT BOTH THE REVERSE HEAD AND BASEPLATE HAD BEEN REMOVED, THE BASEPLATE WAS INVESTIGATED IN (B)(4). THE BASEPLATE PRODUCT ANALYSIS IS PERFORMED IN (B)(4), AS THE BASEPLATE WAS RETURNED AFTER ITS REVISION AND INVESTIGATED IN (B)(4). NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION ISFOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    AFTER A TESS REVERSE IMPLANTATION, THE PATIENT EXPERIENCED A GLENOID SPHERE DISASSEMBLY AND WAS REVISED (THIS FIRST DISASSEMBLY HAS BEEN REPORTED UNDER THE (B)(4)). UNFORTUNATELY, THE PATIENT EXPERIENCED AGAIN A GLENOSPHERE DISASSEMBLY AFTER THIS REVISION. THE SPHERE IS STILL IMPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533916 TESS GLENOID REVERSE HEAD 41MM TOTAL SHOULDER PROSTHESIS PHX BIOMET FRANCE S.A.R.L. N/A 0001456911

    Patients

    Seq Age Sex Outcome Treatment
    1 Other