BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI GLENOID-PERIPHERAL LOCK SCRW

    MDR report key: 10074745 · Received May 20, 2020

    Report

    Report Number
    1220246-2020-01847
    Event Type
    Injury
    Date Received
    May 20, 2020
    Date of Event
    March 20, 2020
    Report Date
    May 20, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057715
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED, THE DEVICE WAS RETURNED WITH TWO BROKEN LATERAL SCREWS AR-9145-24. THE MOST LIKELY CAUSE OF THE GLENOID SIDED FAILURE IS FALL/ TRAUMA, AS STATED IN THE EVENT DESCRIPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019 A REVERS SHOULDER ARTHROPLASTY WAS PERFORMED. EVERYTHING WENT WELL AND IT WAS FINISHED SUCCESSFULLY. THE SURGEON WAS SATISFIED AFTER THE CASE. THIS WAS ALSO SHOWED ON THE X-RAYS. APPROXIMATELY 6 MONTHS POST-OP THE PATIENT REPORTED SUBSEQUENTLY FAILING WHILE PUTTING ON TROUSERS. HE FELT AN ISSUE. THIS WAS WHEN THE GLENOID SIDE GAVE WAY. IT WAS AN ELECTIVE REVERS AND NOT A FRACTURE REVERS. X-RAYS WERE DONE ON (B)(6) 2020. A REVISION SURGERY IS PLANNED TO BE ON (B)(6) 2020. UPDATE SWIT: 02-APR-2020: FURTHER INFORMATION WAS RECEIVED: THE REVISION SURGERY WENT AHEAD ON (B)(6) 2020 AFTERNOON. IT WAS REVISED WITH THE NEW MODULAR GLENOID SYSTEM, SUCCESSFULLY USING AN ILIAC CREST GRAFT. EVERYTHING WENT VERY WELL. THE FAILED DEVICES WERE RETRIEVED, HOWEVER BOTH PERIPHERAL SCREWS WERE BROKEN AND THE TIPS REMAIN IN THE PATIENT. BASEPLATE, CENTRAL SCREW & REMAINING PORTION OF PERIPHERAL SCREWS X 2 WILL BE RETURNED ASSEMBLED. ALSO FROM THE HUMERAL SIDE THE CUP AND LINER, WHICH NEEDED TO BE REMOVED FOR ACCESS, WILL BE RETURNED. THERE WAS NO ISSUE WITH THE HUMERAL SIDE, HOWEVER THEY WILL BE RETURNED REGARDLESS. FOLLOW-UP UPDATE ON 29-APR-2020: FURTHER INFORMATION WAS PROVIDED THAT THE PATIENT WAS ELDERLY AND THE BONE QUALITY WAS NOT IN TOP CONDITION BUT ALSO NOT TOO BAD. THE DAMAGE TO THE IMPLANTS OCCURRED (AS THE PATIENT CLAIMS) WHEN PUTTING ON TROUSERS, THIS NECESSITATED THE REVISION, THEY DID NOT BREAK ON REMOVAL, THEY WERE ALREADY BROKEN FROM WHATEVER TRAUMA THEY SUFFERED. IT WAS FURTHER REPORTED THAT IT IS VERY UNLIKELY THAT JUST PUTTING ON TROUSERS CAUSED BOTH SCREWS TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538925 UNI GLENOID-PERIPHERAL LOCK SCRW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW 19.00006 00888867057715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other