BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SMILES TKR REPLACEMENT IMPLANT

    MDR report key: 4373345 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00125
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    October 24, 2012
    Report Date
    November 12, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K1200992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. A REVIEW OF THE RADIOGRAPHIC IMAGES SHOWED THAT LOOSENING HAS OCCURRED. THE IM STEM INSIDE BOTH THE TIBIAL AND FEMORAL CANALS ARE LOOSE. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. REQUESTS ARE BEING MADE FOR ADDITIONAL INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS SMILES TOTAL KNEE REPLACEMENT (K120992).

    Additional Manufacturer Narrative · 1

    A NEW IMPLANT WAS ORDERED FOR THIS PATIENT BUT THERE IS NO EVIDENCE THE IMPLANT WAS USED. A DEFINITIVE ROOT CAUSE OF THE ASEPTIC LOOSENING HAS BEEN IDENTIFIED. ASEPTIC LOOSENING IS A WELL-KNOWN MODE OF FAILURE FOR ORTHOPAEDIC IMPLANTS, WHICH MAY OCCUR AS AN EARLY OR A LATE COMPLICATION. THE LOOSENING COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY LEVELS OR DISEASE PROGRESSION AND/OR SURGICAL FACTORS OR PREFERENCES AND NOT NECESSARILY RELATED TO THE DEVICE ITSELF. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING PAIN SINCE (B)(6) 2012 AND INDICATED THAT A REVISION PROCEDURE WILL BE REQUIRED FOR PAIN RELIEF. THIS IS A FINAL SUPPLEMENTAL REPORT FOR 3004105610-2014-00125 (REF: (B)(4)).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PT HAS BEEN EXPERIENCING PAIN SINCE (B)(6) 2012 AND INDICATED THAT A REVISION PROCEDURE WILL BE REQUIRED FOR PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847139 CUSTOM SMILES TKR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME13897

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other