BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL GLENOID - CENTRAL SCREW 15MM

    MDR report key: 10159980 · Received June 16, 2020

    Report

    Report Number
    1220246-2020-01902
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    May 18, 2020
    Report Date
    June 16, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057920
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAS STATED THAT THE POSITION OF THE IMPLANTED BASE PLATE IS NOT IN A PROPER POSITION AND THEREFORE THE SURGEON DECIDED TO PERFORM A REVISION SURGERY. DURING THE REVISION SURGERY THE SURGEON DECIDED TO MAKE AN EASIER ACCESS TO THE GLENOID TO REPLACE THE WHOLE PROSTHESES. IT WAS FURTHER REPORTED THAT IT WAS FOUND ON THE X-RAY THAT DUE TO THE POSITION OF THE BASE PLATE A SCAPULAR NOTCHING WAS CAUSED. THE FOLLOWING IMPLANTS WERE EXPLANTED: BASE PLATE AR-9500-01 (PART NUMBER UNKNOWN AS THE PROVIDED ONE IS INCORRECT). GLENOSPHERE AR-9504S-04, STOCK AR-9501-08CPC, 2X PERIPHERE SCREWS (LOCKING) (PART NUMBER UNKNOWN), CENTRAL SCREWS (LOCKING) (PART NUMBER UNKNOWN), PE-INLAY (PART NUMBER UNKNOWN). UPDATE 07-JUN-2020: FURTHER INFORMATION WERE PROVIDED THAT THE BASE PLATE WAS NOT OPTIMALLY PLACED AND THE PLATE DID NOT SINK. DURING THE SURGERY IT WAS ALSO DISCOVERED THAT THE PLATE HAD GOOD OSSEOINTEGRATION. THE SIZE THE CENTRAL SCREW IS AN AR-9165-15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624400 UNIVERSAL GLENOID - CENTRAL SCREW 15MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNIVERSAL GLENOID - CENTRAL SCREW 15MM UNK 00888867057920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other