BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINK ENDO-MODEL-M ROTATIONAL KNEE SYSTEM

    MDR report key: 3122623 · Received May 15, 2013

    Report

    Report Number
    9610548-2013-00002
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    May 14, 2013
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    PMA / PMN Number
    K821476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER WAS CONTACTED TO RECEIVE MORE INFORMATION AND INVESTIGATION MATERIAL E.G. X-RAY IMAGES, SURGERY REPORT, COMPLAINT SAMPLE. THIS EVENT OCCURRED OUTSIDE OF THE U.S. AND INVOLVED A PRODUCT THAT WAS MANUFACTURED OUTSIDE OF THE U.S. HOWEVER, BECAUSE THE LINK ENDO-MODEL - M ROTATIONAL KNEE PROSTHESIS ALSO IS MARKETED IN THE U.S. LINK IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 1

    REVISION SURGERY 1: EXCHANGE OF FEMORAL COMPONENT IN 2012. REASON UNKNOWN. REVISION SURGERY 2: EXCHANGE OF PROSTHESIS ON (B)(6) 2013 AFTER THE PATIENT FALL DOWN IN (B)(6) 2012. BESIDE THIS ALSO AN INFECT OF THE JOINT WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214855 LINK ENDO-MODEL-M ROTATIONAL KNEE SYSTEM ROTATIONAL KNEE SYSTEM, MODULAR KRO WALDEMAR LINK GMBH & CO. KG 15-2812/11

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R