BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL COMP,SINGLECOATED US VERSION, LARGE

    MDR report key: 5308623 · Received December 17, 2015

    Report

    Report Number
    0008031020-2015-00518
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    October 15, 2014
    Report Date
    May 5, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. UNKNOWN STAR TIBIAL COMPONENT: LARGE (33MM X 40MM). WITH GUIDANCE FROM THE MDR POLICY BRANCH OF THE FDA, MDR REPORTED BY STRYKER (B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM SMALL BONE INNOVATION, INC. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY (B)(4) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF (B)(4) ON AUGUST 1, 2014.  STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    PRODUCT INQUIRY STATED THE TIBIAL COMP, SINGLECOATED US VERSION, LARGE, THE SLIDING CORE UHMPWE, 9MM AND THE TALAR COMP, SINGLE COATED US VERS MEDIUM, RIGHT TO BE THE SUBJECT PRODUCTS. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. THE DEVICES WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THUS, WE EXCLUDED DEVIATIONS IN MATERIAL AND MANUFACTURING. A PHYSICAL EXAMINATION COULD NOT BE CARRIED OUT AS THE DEVICES WERE NOT AVAILABLE (STILL IMPLANTED). IN THE CASE PRESENTED A MALE PATIENT HAD BEEN TREATED WITH STAR ON (B)(6) 2013 DUE TO A PRIMARY ARTHROSIS OF THE RIGHT ANKLE. A ¿MEDIAL FACET DISEASE¿ HAD BEEN DIAGNOSED ON (B)(6) 2014 IN THE LEFT (NON-STAR IMPLANTED) ANKLE. AFTER THE STAR ANKLE ARTHROPLASTY IN 2013 THE PATIENT RETURNED TO THE HOSPITAL FOR THE 12- / 24-MONTH FOLLOW UP VISIT ON (B)(6) 2014 / (B)(6) 2015. BOTH FOLLOW UP EXAMINATIONS REVEALED NO FUNCTIONAL DIFFICULTIES FOR THE AFFECTED ANKLE. FURTHERMORE NO SENSORY, MOTOR OR NEUROLOGIC DEFICIT HAD BEEN IDENTIFIED. THE LIGAMENT SUPPORT WAS FOUND TO BE ADEQUATE. A/P AND LATERAL WEIGHT-BEARING X-RAYS WERE TAKEN DURING BOTH FOLLOW UP EXAMINATIONS SHOWING THE DEVICES BEING INTACT AND WELL POSITIONED. RADIOLOGICAL CHANGES (SUCH AS TILTING, RADIOLUCENCIES, MIGRATION OR OSTEOLYSIS) WERE NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION AND REFERRING TO THE FOLLOW UP EXAMINATIONS, WHICH REVEALED THE DEVICES BEING INTACT AND WELL POSITIONED, A DEFICIENCY OF THE DEVICES IN QUESTION COULD NOT BE VERIFIED. A CORRELATION BETWEEN THE ¿MEDIAL FACET DISEASE¿ AND THE IMPLANTED STAR ANKLE PROSTHESIS COULD BE EXCLUDED AS THE REPORTED FACET DISEASE HAD OCCURRED IN THE LEFT (NON-STAR IMPLANTED) ANKLE. NEVERTHELESS THE EXACT ROOT CAUSE FOR THE ¿MEDIAL FACET DISEASE¿ COULD NOT BE DETERMINED DUE TO MISSING INFORMATION, BUT WAS PATIENT RELATED. IN CASE ANY RELEVANT CLINICAL INFORMATION SHOULD BECOME AVAILABLE, WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND CHANGE THE ROOT CAUSE.

    Description of Event or Problem · 1

    MEDIAL FACET DISEASE IN LEFT ANKLE.

    Description of Event or Problem · 1

    MEDIAL FACET DISEASE IN LEFT ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834904 TIBIAL COMP,SINGLECOATED US VERSION, LARGE PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 1301180940

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other