BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURO MENISCAL COMPONENT F2 22MM

    MDR report key: 4358126 · Received December 9, 2014

    Report

    Report Number
    3005673311-2014-00095
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    April 9, 2014
    Report Date
    November 19, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KRO
    PMA / PMN Number
    K101815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K): K120955. US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFR SITE EVAL: EVAL ON-GOING AT MFG SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). KINETICALLY MEDIALLY ACTIVE PT UNDERWENT RE-OPERATION (B)(6) 2012 DUE TO MECHANICAL FAILURE AND TOTAL INSUFFICIENCY OF LATERAL LIGAMENTS. PRIMARY IMPLANTS WERE CHANGED TO ENDURO. NINE MONTHS LATER, PT EXPERIENCED RUPTURING OF THE KNEE JOINT DURING WALKING. FRACTURE OF THE ROTARY TIBIAL PLUG IN THE PLACE OF THE HINGE RING OF THE FEMORAL COMPONENT WAS CONFIRMED DURING REVISION SURGERY ON (B)(6) 2013. PT EXPERIENCED BREAKAGE OF THE ROTARY TIBIAL PLUG IN THE HINGE RING 8 MONTHS AFTER THIS REVISION SURGERY. SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2014. IT WAS FOUND DURING THIS OPERATION THAT THERE WAS A FRACTURE OF THE ROTARY TIBIAL PLUG IN THE PLACE OF CROSSING OF THE PLUG AND A SCREW THREAD OF THE SAFETY NUT. DURING THE SURGERY, IT WAS NOTED THAT THERE WERE DAMAGES (IMPRESSIONS) OF THE METAL FEMORAL COMPONENT IN THE PLACE OF THE ARCH OF CROSSING OF THE FEMORAL BOX AND FEMORAL-PATERNALLY SULK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797049 ENDURO MENISCAL COMPONENT F2 22MM KRO AESCULAP AG & CO. KG NR886M 51783449

    Patients

    Seq Age Sex Outcome Treatment
    1