BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METS TOTAL KNEE REPLACEMENT

    MDR report key: 6157501 · Received December 9, 2016

    Report

    Report Number
    3004105610-2016-00118
    Event Type
    Injury
    Date Received
    December 9, 2016
    Report Date
    November 17, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K120992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. FURTHER INFORMATION HAS BEEN REQUESTED IN ORDER TO COMPLETE THE INVESTIGATION. A SUPPLEMENTAL WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IMPLANT REMAINS IN SITU. STANMORE IMPLANTS WORLDWIDE (SIW) WAS INFORMED OF THE SURGEONS' INTENTION TO PERFORM A REVISION/REBUSHING SURGERY IN (B)(6) 2016. HOWEVER REQUESTS FOR FURTHER INFORMATION HAVE CONFIRMED THAT NO REVISION /REBUSHING EVENT HAS TAKEN PLACE TWO MONTHS LATER, WITH NO REVISION/REBUSHING SURGERY SCHEDULED. THEREFORE THIS COMPLAINT DOES NOT MEET THE DEFINITION OF A COMPLAINT AND WILL BE CLOSED. WHEN SIW BECOMES AWARE OF A REVISION/REBUSHING EVENT THIS WILL BE INVESTIGATED AS PER REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WILL BE UNDERGOING A REVISION PROCEDURE REQUIRING A POLY EXCHANGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WILL BE UNDERGOING A REVISION PROCEDURE REQUIRING A POLY EXCHANGE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00118 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813572 METS TOTAL KNEE REPLACEMENT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD MKRHP/STD AND MPTFC/LSTD A10731 AND A11265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FEMORAL KNEE COMPONENT MPTFC/LSTD LOT A11265| TIBIAL POLYETHYLENE ASSEMBLY MKRHP/STD LOT A10731