BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY

    MDR report key: 10022814 · Received May 4, 2020

    Report

    Report Number
    3004154314-2020-00002
    Event Type
    Injury
    Date Received
    May 4, 2020
    Report Date
    April 6, 2020
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KWD
    PMA / PMN Number
    K131377
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INQUIRED IF OTHER PATIENTS UNDERGO A PHYSICAL THERAPY FOLLOWING THE HEMICAP SURGERY AND SHE IS ALSO CONCERNED ABOUT NOT BEING ABLE TO WEAR HEELS EVEN AFTER 5 MONTHS OUT. THE REASON FOR PATIENT'S COMPLAINT CANNOT BE ASCERTAINED DUE TO LACK OF INFORMATION REQUIRED FOR THE INVESTIGATION. SINCE NO DEVICE OR LOT INFORMATION WAS PROVIDED, A REVIEW OF DEVICE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. SEVERAL FACTORS SUCH AS STRESS/ PHYSICAL LOADS ON THE IMPLANTS, VASCULARITY OF THE IMPLANTATION SITE, SURGICAL TECHNIQUES EMPLOYED DURING IMPLANTATION, PATIENT FACTORS (SUCH AS AGE, PRE-EXISTING CONDITIONS, CURRENT STATE OF THE IMMUNE SYSTEM, BONE QUALITY, AND SENSITIVITY TO DEVICE MATERIALS), AND PATIENT POST-OP COMPLIANCE TO REHABILITATION PROCEDURES ETC. CAN HAVE IMPACT ON THE FUNCTIONAL EFFECTIVENESS OF THE IMPLANTED DEVICES. THE PATIENT WAS PROVIDED A POST-OP PROTOCOL AND WAS ADVISED TO CONSULT THEIR TREATING SURGEON FOR FURTHER CONCERNS REGARDING IMPLANT AND PHYSICAL THERAPY. THE COMPLAINT WILL BE CLOSED AT THIS TIME AND ANY NEW INFORMATION RECEIVED WILL BE REVIEWED AND REPORTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE PATIENT REACHED OUT TO ARTHROSURFACE VIA WEBSITE TO INQUIRE REGARDING PHYSICAL THERAPY AFTER RECEIVING THE HEMICAP. SHE RECEIVED THE IMPLANT FIVE MONTHS AGO AND CURRENTLY CANNOT WEAR HEELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486444 HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY TOE HEMICAP KWD ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other