BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS ASCEND FLEX HUMERAL STEM

    MDR report key: 9937292 · Received April 8, 2020

    Report

    Report Number
    3000931034-2020-00049
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 9, 2020
    Product Code
    KWS
    PMA / PMN Number
    K122698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    SHOULDER TRAUMA IN 2017, WITH RUPTURE OF GREATER TUBEROSITY AND HUMERAL HEAD IMPACTION AND ROTATION. IN (B)(6) 2019 IMPLANTION OF A PYC HEMI FLEX BECAUSE OF PERSISTENT PAIN. THIS PAIN DID NOT STOP AND THE DR FOUND THAT HE HAD WRONGLY POSITIONED THE PROSTHETIC HEAD, BECAUSE OF THE LACK OF PROPER REFERENCE DUE TO TRAUMATIC HEAD ROTATION. SO THE PROSTHETIC HEAD WAS TOO PROUD (OVERSTUFFING THE GLENOID) AND WRONGLY ORIENTATED (WAS ABOUT AT 150° AND SHOULD HAVE BEEN AT 137°). AFTER 8 MONTHS HE REOPERATES, REMOVE HEAD AND STEM, RECUT AND REPLACE BY A CEMENTED STEM AT 137° WITH THE SAME DIMENSION HEAD 41X15 HIGH OFFSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402660 AEQUALIS ASCEND FLEX HUMERAL STEM SHOULDER JOINT METAL PROSTHESIS KWS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other