BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALAR COMP,SINGLE COATED US VERS SMALL, LEFT

    MDR report key: 5116890 · Received October 1, 2015

    Report

    Report Number
    0008031020-2015-00395
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 9, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON (B)(6) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. UNK STAR TALAR COMPONENT.DEVICE WILL NOT BE RETURNED FOR EVALUATION

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED THE TALAR COMPONENT STAR TOTAL ANKLE, TIBIAL COMPONENT STAR TOTAL ANKLE AS WELL AS THE SLIDING CORE 8MM TO BE SUBJECT PRODUCTS. A REVIEW OF THE DHR FOR THE TALAR COMPONENT, TIBIAL COMPONENT AND SLIDING CORE AS WELL REVEALED NO DISCREPANCIES. IN THE CASE PRESENTED A MALE PATIENT HAD BEEN TREATED WITH A (B)(4) TOTAL ANKLE REPLACEMENT (STAR) ON (B)(6) 2012) FOR LEFT ANKLE TRAUMATIC ARTHROPATHY WITH TOTAL ANKLE ARTHROPLASTY WITH STAR IMPLANT. THE PROGRESS NOTES ((B)(6) 2015) STATES: ¿¿ THE PATIENT FEEL ABOUT 2 WEEKS AGO WHEN HE INVERTED HIS ANKLE. X-RAY EXAMINATION SHOWED THE LATERAL SIDE TO BE STRETCHED OUT. HE HAD TIPPED THIS THING INTO A GREAT DEAL OF VARUS¿.¿ X-RAY IMAGES PROVIDED: THERE WERE 3 X-RAY IMAGE PROVIDE (VERY SMALL IN SIZE) AND OF LIMITED PRINTING QUALITY ¿ DATED (B)(6) 2015. X-RAYS SHOWS THE LATERAL SIDE TO BE STRETCHED OUT. ANKLE IN VARUS. THE RECEIVED TALAR COMPONENT DOES NOT SHOW EVIDENT DAMAGE. IMPLANT LOOSENING IN GENERAL HAD BEEN EXPERIENCED AND IS NOMINATED IN THE SCIENTIFIC LITERATURE. IT DOES NOT PRESENT AN UNANTICIPATED EVENT IN ITSELF. BASED ON THE ABOVE INFORMATION EVENT WAS NOT RELATED TO A DEFICIENCY OF THE DEVICE. IMPLANT LOOSENING / REMOVAL IS LISTED IN THE IFU AS AN ADVERSE EFFECT.

    Description of Event or Problem · 1

    CONVERTING STAR TO AN IN-BONE ON (B)(6) 2015. ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED PER SURGEON PROGRESS NOTES PATIENT CLAIMS THAT THEY FELL ABOUT THREE WEEKS AGO AND INVERTED ANKLE. PATIENT] HAS HAD INCREASED SWELLING SINCE THAT TIME. PAIN HAS IMPROVED SOME OVER THE PAST WEEK. BASED ON X-RAYS PROSTHESIS HAS TIPPED MORE WITH THIS INJURY. X-RAY SHOWS THE LATERAL SIDE TO BE STRETCHED OUT. GOING TO NEED TO REVISED THIS AND CONVERT TO AN IN-BONE. REVISED TO IN-BONE.

    Description of Event or Problem · 1

    CONVERTING STAR TO AN IN-BONE ON (B)(6) 2015. ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED PER SURGEON PROGRESS NOTES PATIENT CLAIMS THAT THEY FELL ABOUT THREE WEEKS AGO AND INVERTED ANKLE. PATIENT HAS HAD INCREASED SWELLING SINCE THAT TIME. PAIN HAS IMPROVED SOME OVER THE PAST WEEK. BASED ON X-RAYS PROSTHESIS HAS TIPPED MORE WITH THIS INJURY. X-RAY SHOWS THE LATERAL SIDE TO BE STRETCHED OUT. GOING TO NEED TO REVISED THIS AND CONVERT TO AN IN-BONE. REVISED TO IN-BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650570 TALAR COMP,SINGLE COATED US VERS SMALL, LEFT PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 091204/0910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention