BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS REVERS GLENO 42 +4 LAT

    MDR report key: 8861324 · Received August 5, 2019

    Report

    Report Number
    1220246-2019-01227
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    December 18, 2018
    Report Date
    August 5, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867061347
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    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 DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. 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 APPROXIMATELY ONE AND A HALF WEEKS AFTER HAVING A PRIMARY REVERSE SHOULDER ARTHROPLASTY PROCEDURE, THE PATIENT'S GLENOSPHERE DISASSOCIATED POST-OP. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE THAT TOOK PLACE ON (B)(6) 2018: AR-9507S // LOT: 10232680, AR-9165-25NL // LOT: 10221985, AR-9120-03 // LOT: 18.00430, AR-9145-30 // LOT: 18.00677, AR-9145-24 // LOT: 18.00574, AR-9504L-04 // LOT: 18.00719, AR-9501-06P // LOT: 170151305, AR-9502F-42CPC // LOT: 170161207, AR-9550-06 // LOT: 18.00355, AR-9503L-03C // LOT: 18.00110. IT IS UNKNOWN IF THE PATIENT WAS EXPERIENCING ANY PAIN OR DISCOMFORT. THE DISASSOCIATION WAS DISCOVERED APPROXIMATELY ONE AND A HALF WEEKS POST-OP DURING PHYSICAL THERAPY. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018. THE REP STATED COPIES OF X-RAY'S ARE NOT AVAILABLE, NOR WERE ANY PICTURES TAKEN. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE FOLLOWING ARTHREX PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9504L-04 // LOT: 18.00719, AR-9550-06 // LOT: 18.00355, AR-9503L-03C // LOT: 18.00110. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE REVISION PROCEDURE: AR-9504L-04 // LOT: 18.00719, AR-9550-06 // LOT: 160147410, AR-9503L-03C // LOT: 170005110. ADDITIONAL INFORMATION RECEIVED ON 07/18/2019: THE REP CONFIRMED ALL EXPLANTED DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654877 UNIVERS REVERS GLENO 42 +4 LAT SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNIVERS REVERS GLENO 42 +4 LAT 18.00719 00888867061347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other