BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SMILES TOTAL KNEE REPLACEMENT (TKR)

    MDR report key: 4373426 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00165
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REBUSH PROCEDURE WAS SUCCESSFULLY PERFORMED WITH NO REPORTED COMPLICATIONS. AS THE CIRCLIP, OR ANY PRE-OPERATIVE X-RAY WAS NOT PROVIDED TO STANMORE, WHICH WOULD SERVE TO CONFIRM THE COMPLAINT, A DETERMINATION AS TO THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED. TYPICALLY, A DISENGAGED CIRCLIP IS THE RESULT OF AN IMPROPER INSERTION AT THE TIME OF SURGERY. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM DEVICE IS SIMILAR TO THE METS SMILES TOTAL KNEE REPLACEMENT (K120992).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2014 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2014 DUE TO INSTABILITY OF THE KNEE DUE TO A LOOSE AXLE CAP.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2014 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2014 DUE TO INSTABILITY OF THE KNEE DUE TO A LOOSE AXLE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847330 CUSTOM SMILES TOTAL KNEE REPLACEMENT (TKR) LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 18254 PIN 18254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R