BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TKR

    MDR report key: 4360984 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00083
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    April 10, 2012
    Report Date
    April 23, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE SMILES TKR (K120992).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A CUSTOM TOTAL KNEE REPLACEMENT OF (B)(6) 2010 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO LOOSENING AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837646 CUSTOM TKR TOTAL KNEE REPLACEMENT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME15426

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention