BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL TIBIA

    MDR report key: 4030402 · Received July 21, 2014

    Report

    Report Number
    3004105610-2014-00003
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON WAS PERFORMING A REBUSHING PROCEDURE AFTER 11 YEARS IN SITU. DURING THE PROCEDURE, THE FEMORAL COMPONENT CAME LOOSE FROM THE CEMENTED STEM. THE SURGEON THEN ORDERED AND SUCCESSFULLY IMPLANTED A NEW FEMORAL COMPONENT AND COMPLETED THE REBUSHING WITH NO REPORTED COMPLICATIONS. AFTER INVESTIGATION OF THE EXPLANTED COMPONENTS AND A REVIEW OF IMAGING, IT IS NOT POSSIBLE TO DETERMINE A SPECIFIC REASON FOR THE REPORTED ISSUE ALTHOUGH THE ACTIVE AGE OF THE IMPLANT MAY POTENTIALLY BE A CONTRIBUTOR TO THIS TYPE OF EVENT. A REVIEW OF THE BATCH RECORDS REVEALED NO EVIDENCE THAT NON-CONFORMING PRODUCTS WERE RELEASED FROM THIS BATCH. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    THE CLINICIAN DECIDED TO LEAVE THE IMPLANT IN THE PATIENT AND REQUEST STANMORE IMPLANTS TO MANUFACTURE A CUSTOM DISTAL FEMUR TO REPLACE THE CURRENT IMPLANT. THE REVISION SURGERY IS PLANNED FOR (B)(6) 2014. THE EXPLANTED DEVICE IS REQUESTED TO BE RETURNED FOR EVALUATION. THE PT WILL HAVE LIMITED MOBILITY OF THE LIMB UNTIL THE IMPLANT IS SITU IS REVISED. THIS PRODUCT IS SIMILAR TO THE DEVICE APPROVED UNDER 510K K120992.

    Description of Event or Problem · 1

    FROM THE CUSTOMER/PATIENT-SPECIFIC IMPLANT SURGERY REPORT RECEIVED ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT WAS OPERATED FOR REBUSHING PROCEDURE. DURING THE OPERATION AFTER REMOVING THE AXLE, IN SITU THE CURVED CONDYLAR PIECE ATTACHED TO THE FEMORAL COMPONENT CAME AWAY FROM THE CEMENTED STEM, WHICH WAS STILL FIRMLY CEMENTED INTO THE FEMUR. REBUSHING IS REPLACEMENT OF UHMWPE COMPONENTS OF THE IMPLANT.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426680 CUSTOM PROXIMAL TIBIA PROX TIBIA JDI STANMORE IMPLANTS WORLDWIDE BME10425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR