BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS REVERS FRACTURE ADAPTER TRUNION

    MDR report key: 19605334 · Received June 25, 2024

    Report

    Report Number
    1220246-2024-06408
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    September 19, 2023
    Report Date
    June 11, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSD
    UDI-DI
    00888867306004
    PMA / PMN Number
    K181555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON MAY 1ST, 2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED, RESULTING IN REVISION SURGERY TO A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 WITH CTA HEAD AND GLENOID GRAFTING. ADDITIONAL INFORMATION RECEIVED ON 5/16/2024. THE ORIGINAL TSA PROCEDURE WAS PERFORMED ON 5/5/2009. THE IMPLANTS USED IN THE ORIGINAL PROCEDURE WERE PRODUCTS FROM ANOTHER MANUFACTURING COMPANY. ON (B)(6) 2023, THE PATIENT WAS SEEN BY THE SURGEON DUE TO SEVERAL YEARS OF PAIN, AND IT WAS CONFIRMED VIA CT ARTHROGRAM THAT THE IMPLANTS HAD LOOSENED, AND THE PATIENT HAD SEVERAL ROTATOR CUFF TEARS. ON (B)(6) 2023, THE PATIENT WAS REVISED FROM A TSA TO A HEMIARTHROPLASTY IN WHICH THE SURGEON IMPLANTED A CTA HEAD AND GLENOID BONE GRAFT. SOON AFTER THE SURGERY, THE PATIENT STILL EXPERIENCED PAIN AND THE SURGEON SUGGESTED THE PATIENT MIGHT BE A CANDIDATE FOR A STATE PROCEDURE TO PUT IN A BASEPLATE. ON (B)(6) 2024, THE PATIENT UNDERWENT A SECOND REVISION SURGERY TO CONVERT THE HEMIARTHROPLASTY TO A REVERS TSA WITH A REPLANT OF THE GLENOID BASEPLATE. ADDITIONAL INFORMATION RECEIVED ON 5/29/2024: DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, 36, LOT NUMBER 23.01972, AN AR-9555-15 ARTHREX UNIVERS REVERS SPACER 36 + 15 MM LOT NUMBER 22.02863, AND AN AR-9503S-06C ARTHREX UNIVERS REVERS HUMERAL INSERT SMALL / 36 / +6 / CONSTRAINED LOT NUMBER 23.02025 WERE IMPLANTED. DURING REVISION SURGERY ON (B)(6) 2023, AN AR-9501-FX6WT UNIVERS REVERS FRACTURE ADAPTER, SIZE 6-9, WIDE + TA LL LOT NUMBER 98310, AN AR-9501-09PT ARTHREX UNIVERS REVERS HUMERAL STEM, SIZE 9 LOT NUMBER 22.04154, AN AR-9501FTK UNIVERS REVERS FRACTURE ADAPTER, TRUNION LOT NUMBER 21.00857, AN AR-9501-08P ARTHREX UNIVERS REVERS HUMERAL STEM, SIZE 8 LOT NUMBER 22.03564 AND AN AR-9556-22RCA UNIVERS REVERS CA HUMERAL HEAD 56/22 LOT NUMBER 14973709 WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435552 UNIVERS REVERS FRACTURE ADAPTER TRUNION PROSTHESIS, SHOULDER, CEMENTED HSD ARTHREX, INC. UNIVERS REVERS FRACTURE ADAPTER TRUNION 21.00857 00888867306004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other