BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOURED ARTICULAR PROSTHETIC (CAP) HUMERAL HEAD RESURFACING SYSTEM

    MDR report key: 7239344 · Received February 2, 2018

    Report

    Report Number
    3004154314-2018-00002
    Event Type
    Injury
    Date Received
    February 2, 2018
    Report Date
    January 5, 2018
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    HSD
    PMA / PMN Number
    K023096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    AN OVO CASE RECORDED WITH SUBJECT TAPER POST COMPONENT LOT (75AD2205) COULD NOT BE LOCATED FOR (B)(6) 2014 (PER COMPLAINANT'S INFORMATION). TO DATE, NO COMPLAINTS PERTAINING TO PAIN OR LOOSENING HAVE BEEN REPORTED FOR THIS LOT. THE DHRS OF THE INCOMING AS WELL AS FINAL INSPECTION LOTS WERE REVIEWED. THE MATERIAL CERTS, QIPS INDICATE THAT THE PARTS WERE BUILT TO SPECIFICATION. THERE WERE NO REJECTS OR SCRAPPED PARTS FROM THIS LOT. NOTE THAT THE TAPER POST LOT IN QUESTION WAS PART OF A VOLUNTRAY RECALL (RECALL # Z-1114-2015) INITITADE DUE TO REGULATORY CONCERNS BUT NOT DUE TO ANY COMPLAINTS, SAFETY OR EFFICACY CONCERNS. HOWEVER, THE DEVICE IS CURRENTLY ACTIVE IN THE EU AND OTHER OUS MARKETS WITH SAFETY AND EFFICACY DATA ON FILE. THE EXACT REASON FOR PATIENT'S PAIN COULD NOT BE CONCLUDED DUE TO INSUFFICIENT INFORMATION PROVIDED BY THE COMPLAINANT. AS SUCH, THE REASON FOR LOOSENING IS UNKNOWN AS THE DEVICE COMPONENTS HAVE NOT BEEN RETURNED FOR INVESTIGATION. THE PATIENT HAS BEEN REVISED IN (B)(6) 2017 AND ALL ARTHROSURFACE COMPONENTS HAVE SINCE BEEN EXPLANTED. ANY FURTHER INFORMATION RECEIVED REGARDING THIS COMPLAINT WILL BE REPORTED THROUGH SUPPLEMENTAL MDRS AS REQUIRED.

    Description of Event or Problem · 1

    ARTHROSURFACE RECEIVED A LEGAL NOTICE ON ( B)(6) 2018 FROM (B)(6) THE NOTICE STATES THAT THEIR CLIENT RECEIVED AN OVO IMPLANT AROUND (B)(6) 2014. ON (B)(6) 2017, THE PATIENT WAS REVISED AS THE OVO IMPLANT CAME LOOSE. THEY ALSO STATE PATIENT IS NOW IN PAIN DUE TO ARTHROSURFACE HEMICAP RESURFACING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82810 CONTOURED ARTICULAR PROSTHETIC (CAP) HUMERAL HEAD RESURFACING SYSTEM HEMI SHOULDER RESURFACING PROSTHESIS HSD ARTHROSURFACE, INC. 8156-0032-W 75AD2205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other