BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SR MCP SURFACE REPLACEMENT JOINT IMPLANTS

    MDR report key: 1252392 · Received December 4, 2008

    Report

    Report Number
    3003640913-2008-00006
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 6, 2008
    Report Date
    December 5, 2008
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    KYJ
    PMA / PMN Number
    H010001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER FOR THE TWO IMPLANTS OF THE SAME PART NUMBER AT THE INITIAL IMPLANT SURGERY WERE 39740001 AND 39740002. THE SURGERY RECORD DID NOT IDENTIFY WHICH DEVICE WAS IMPLANTED IN WHICH FINGER SO BOTH DEVICE HISTORY RECORDS WERE REVIEWED. DEVICE HISTORY RECORDS FOR BOTH LOTS SHOWED NO ANOMALIES. CAUSE OF EXCESS WEAR COULD NOT BE DETERMINED. PATIENT WAS A PIANO PLAYER AND POSSIBLY OVER-USED THE JOINT EARLY IN REHABILITATION.

    Description of Event or Problem · 1

    EXPLANT OF A SIZE 2 SR MCP JOINT IMPLANT DUE TO SUBLUXATION OF FINGER AND EXCESSIVE WEAR OF PROXIMAL COMPONENT. TWO SR MCP PROSTHESES WERE IMPLANTED IN 2008 IN SAME HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SR MCP SURFACE REPLACEMENT JOINT IMPLANTS METACARPAL JOINT PROSTHESES KYJ SMALL BONE INNOVATIONS, INC. 39740001 OR 0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other