BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMICAP/UNICAP RESURFACING PROSTHESIS

    MDR report key: 2868295 · Received December 7, 2012

    Report

    Report Number
    3004154314-2012-00006
    Event Type
    Other
    Date Received
    December 7, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    HSD
    PMA / PMN Number
    K071413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OF THE FOLLOWING ARTHROSURFACE COMPONENTS WERE INVOLVED IN THIS CASE: PART#/LOT#/EXPIRATION DATE: U202-0631W/ 75II2517/ SEPTEMBER 2009; PX11-0218-W/75JJ2118 / OCTOBER 2010; PX02-0705-W/ 75KJ0518/ NOVEMBER 2010; P306-0090-W/ 75AK1025/ JANUARY 2011. ADDITIONAL 510K# K050373.

    Description of Event or Problem · 1

    PATIENT COMPLAINED WITH VISIBLE SWELLING OF THE KNEE. SURGEON OPENED KNEE AND DETERMINED THAT KNEE WAS INFECTED. THE SURGEON CONSIDERED LEAVING THE IMPLANTS IN AND ONLY TREATING THE INFECTION BUT DECIDED TO ERR ON THE SIDE OF CAUTION AND REMOVE THE IMPLANTS, THEN TREAT WITH ANTIBIOTIC SPACERS. SURGEON WILL PERFORM A TOTAL KNEE SURGERY AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMICAP/UNICAP RESURFACING PROSTHESIS NONE HSD ARTHROSURFACE, INC. U110-0218-W 75CK1020

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention