BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALACOS

    MDR report key: 20532857 · Received October 24, 2024

    Report

    Report Number
    MW5161559
    Event Type
    Other
    Date Received
    October 24, 2024
    Date of Event
    May 5, 2023
    Report Date
    October 22, 2024
    Manufacturer
    HERAEUS MEDICAL LLC.
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A REPORTER CALLED TO SUBMIT A REPORT ABOUT HER RIGHT KNEE IMPLANTS¿ ADVERSE EFFECTS. SHE SAID EVER SINCE SHE HAD RIGHT KNEE IMPLANTS, SHE IS HAVING CONSTANT PAIN. SHE WAS THINKING THE FIRST 2 OR 3 MONTHS COULD BE SURGICAL RELATED PAIN. HOWEVER, HER PAIN HAS NOT SUBSIDED AT ALL. SHE SAID SHE IS HAVING EXCESSIVE SWELLING ON HER RIGHT KNEE, MOBILITY ISSUES, INABILITY TO BEND, INABILITY TO GO UP AND DOWN THE STAIRS. SHE SAID SHE CANNOT GET UP FROM HER COUCH UNLESS SOMEONE HELPS HER. SHE SAID THE PAIN IS ONGOING REGARDLESS OF THE POSITION SHE IS IN OR ANY ACTIVITIES SHE IS DOING. SHE SAID HER RIGHT KNEE IS WARM TO TOUCH. SHE ALSO SAID HER RIGHT KNEE IS BIGGER THAN THE LEFT ONE, THE RIGHT KNEE MEASURES ABOUT 19¿ IN DIAMETER WHILE THE LEFT ONE IS 17¿. SHE SAID SHE CAN NO LONGER FIT INTO REGULAR JEANS BECAUSE HER RIGHT KNEE IS BIGGER. SHE SAID SHE DID THE REQUIRED PHYSICAL THERAPIES, AND SHE WAS TOLD BY THE PHYSICAL THERAPIST THEY CANNOT HELP HER ANYMORE. ALSO, HER DOCTOR TOLD HER, PER THE X-RAY EVERYTHING IS NORMAL EVEN THOUGH SHE IS HAVING A LOT OF ISSUES. SHE WAS WONDERING IF ANY OF THE DEVICES IMPLANTED IN HER KNEE HAVE BEEN RECALLED. REF REPORTS: MW5161555, MW5161556, MW5161557, MW5161558.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321602 PALACOS BONE CEMENT LOD HERAEUS MEDICAL LLC. 64791159

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female