BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER DEVICE

    MDR report key: 10420512 · Received August 18, 2020

    Report

    Report Number
    3004154314-2020-00005
    Event Type
    Injury
    Date Received
    August 18, 2020
    Report Date
    July 19, 2020
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED AND A ROOT CAUSE FOR THE REPORTED PAIN CANNOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE FOR INVESTIGATION. IT IS UNKNOWN WHETHER THE PATIENT HAD A PARTIAL OR TOTAL SHOULDER ARTHROPLASTY SURGERY. THE DEVICE TYPE AND INFORMATION ARE UNKNOWN. PATIENT WAS ADVISED TO CONSULT THEIR TREATING SURGEON FOR DIAGNOSIS OF THE PAIN. THE INSTRUCTIONS FOR USE (IFU) DOCUMENT LISTS ALL POSSIBLE ADVERSE EFFECTS AND ALL RISKS ARE ADDRESSED IN THE RISK DOCUMENTATION. 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, 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. AS THE PATIENT DID NOT RESPOND TO FOLLOW-UP EMAILS, THE COMPLAINT WILL BE CONSIDERED CLOSED AT THIS TIME. ANY FURTHER INFORMATION RECEIVED WILL BE DOCUMENTED AND REVIEWED FOR REPORTABILITY AND SUBMITTED VIA SUPPLEMENTAL MDRS.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED AN UNKNOWN ARTHROSURFACE SHOULDER IMPLANT ON (B)(6) 2019 AND HAS HAD GOOD RECOVERY. SINCE (B)(6) 2020, THE PATIENT STARTED EXPERIENCING PAIN AND REACHED OUT TO ARTHROSURFACE TO ASK IF ARTHRITIS CAN RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884986 UNKNOWN SHOULDER DEVICE PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other