BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24MM +2 LAT BASEPLATE, MODULAR

    MDR report key: 10540405 · Received September 16, 2020

    Report

    Report Number
    1220246-2020-02163
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 28, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867296497
    PMA / PMN Number
    K173900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED, DESPITE THE DAMAGE OBSERVED ON THE LOCKING SCREW AND THREADS OF THE BASEPLATE, THE SCREW WAS FOUND TO LOCK. NO FURTHER ABNORMALITIES WERE OBSERVED ON THE DEVICE. THE CAUSE OF THE EVENT IS UNDETERMINED.

    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 (B)(6) 2019 A PATIENT HAD A REVERSE SHOULDER PROCEDURE. ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT HAD AN AUTOGRAFT TO THE GLENOID ON HER INITIAL SURGERY AND IT DID NOT APPEAR TO HAVE HEALED. THE SALES REPRESENTATIVE WHO WAS PRESENT DURING THE REVISION REPORTS THAT THE SURGEON HAD MENTIONED IN SURGERY THAT HE BELIEVED THAT THE LOCKING MECHANISM ON THE BASEPLATE MAY NOT HAVE BEEN FUNCTIONING APPROPRIATELY (THE SCREW WAS NOT LOCKED IN). DURING THE ORIGINAL PROCEDURE THE FOLLOWING ARTHREX DEVICES HAD BEEN IMPLANTED: AR-9564-2436-LAT, GLENOSPHERE, LOT 18.00689 , AR-9503S-03, HUMERAL INSERT, LOT 18.00870 , AR-9502F-36CPC, UNIVERS REVERS SUTURE CUP, LOT 170141708, AR-9561-25P, MODULAR CENTRAL POST, LOT 5368 , AR-9560-24-2, MODULAR BASEPLATE, LOT 5408 AR-9562-36NL, PERIPHERAL SCREW NON-LOCKING, LOT 2018001207, AR-9563-36, PERIPHERAL SCREW LOCKING, LOT 2018001490 , AR-9563-40, PERIPHERAL SCREW LOCKING, LOT 2018001491 , AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, LOT 170125705. DURING THE REVISION SURGERY ALL OFF THE ABOVE LISTED ORIGINAL IMPLANTS WERE EXPLANTED, EXCEPT FOR THE AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, WHICH WAS LEFT IN THE PATIENT. EXPLANTED DEVICES WILL BE RETURNED FOR EVALUATION. THE SURGEON COMPLETED THE REVISION BY DOING A HEMI ARTHROPLASTY AND IMPLANTING THE FOLLOWING ARTHREX PRODUCTS: AR-9502-36ARCA, REVERS CA ADAPTER ASSEMBLY, LOT 18.01305 , AR-9544-17RCA, REVERS CA HUMERAL HEAD, LOT 10071302, AR-9502F-36CPC, UNIVERS REVERS SUTURE CUP, LOT 19.00846 . THE ORIGINAL AND REVISION PROCEDURES WERE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006514 24MM +2 LAT BASEPLATE, MODULAR SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. 24MM +2 LAT BASEPLATE, MODULAR 5408 00888867296497

    Patients

    Seq Age Sex Outcome Treatment
    1 Other