BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPACE BALLOON IMPLANT FOR SHOULDER

    MDR report key: 18588851 · Received January 25, 2024

    Report

    Report Number
    MW5150765
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    March 20, 2022
    Report Date
    January 22, 2024
    Manufacturer
    STRYKER/ORTHO-SPACE LTD.
    Product Code
    QPQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD AN INSPACE IMPLANTED IN MY RIGHT SHOULDER ON (B)(4) 2022 WITHIN A FEW DAYS I HAD INCREASED PAIN, SWELLING. MY DR (B)(6) DISREGARDED THE SITUATION UNTIL I COULDN¿T STAND IT AND WENT TO ER WHERE I HAD TO HAVE DEVICE REMOVAL AND 3-4 WASHOUT SURGERIES, IV ANTIBIOTICS. I WAS HOSPITALIZED FOR 44 DAYS. I ALSO HAD AN AKI IN WHICH I DID NOT RECOVER AND HAVE CKD3B. THE WASHOUT CAUSED MUSCLE LOSS, ROTATOR CUFF LOSS, FROZEN SHOULDER, OSTEOMYELITIS. A YEAR LATER I HAD AN ANTIBIOTIC LOADED SPACER PLACED BECAUSE THIS ISSUE REQUIRED ME TO HAVE A REVERSE TOTAL SHOULDER PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798980 INSPACE BALLOON IMPLANT FOR SHOULDER SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ STRYKER/ORTHO-SPACE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Hospitalization| R| O| L| S LEVOTHYROXINE.| LEVOTHYROXINE.| MULTIVITAMIN. | MULTIVITAMIN. | VITAMIN D3.