BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT

    MDR report key: 4884748 · Received July 1, 2015

    Report

    Report Number
    0008031020-2015-00271
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    August 28, 2014
    Report Date
    June 9, 2015
    Manufacturer
    STRYKER GMBH (MDR)
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED ALL THREE IMPLANTS REPORTED TO BE PRIMARY PRODUCTS. NO FURTHER ASSOCIATED PRODUCT WAS REPORTED. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION SINCE THEY ARE STILL IMPLANTED. REVIEW OF THE DEVICE HISTORY RECORDS OF THE REPORTED THREE IMPLANTS WAS DEEMED UNNECESSARY, SINCE NO PRODUCT FAILURE / MALFUNCTION WAS REPORTED. THE PATIENT IS PARTICIPANT OF A CLINICAL STUDY AND THE EVENT WAS REPORTED WITHIN A 2-YEAR POST APPROVAL STUDY TO INVESTIGATE THE STAR ANKLE UNDER ACTUAL CONDITIONS OF USE. EXCERPT FROM ¿CLINICAL RESULTS OF THE STAR ANKLE PROSTHESIS / CLINICAL ASSESSMENT BASED ON A SYSTEMATIC LITERATURE RESEARCH (JANUARY 1998 ¿ FEBRUARY 2015)¿ BY MD. DIPL.-ING. HELMUT MÜCKTER: SIGNIFICANT PAIN (0 ¿ 8 %). IN MOST CASES ANKLE ARTHROPLASTY COMES WITH SIGNIFICANT PAIN RELIEF. APPROX. 60 % ¿ 80 % OF THE PATIENTS ARE PAIN FREE OR NEARLY PAIN FREE IN THE FOLLOW UP, APPROX. 20 % ¿ 30 % HAVE MODERATE PAIN (E.G. STARTING PAIN), BUT LESS THAN 10 % OF THE PATIENTS HAVE REMAINING PAIN OR SYMPTOMATIC PAIN DUE TO A MALPOSITIONING OR A MALFUNCTION OF THE ENDOPROSTHESIS OR DUE TO ADDITIONAL ARTHROSIS OF THE ADJACENT JOINTS (MOSTLY IN RHEUMATOID ARTHRITIS) OR SOFT TISSUE AFFECTIONS. TREATMENT IS DEPENDING ON THE PARTICULAR REASON FOR PAIN. ALL REPORTED POTENTIAL RISKS AND COMPLICATIONS NOMINATED ABOVE REPRESENT TYPICAL COMPLICATIONS OF ANKLE ARTHROPLASTY AND ARE NOT RELATED TO THE PARTICULAR DESIGN OF STAR.¿ FURTHER INFORMATION SUCH AS X-RAYS, SURGERY REPORT AND MEDICAL RECORDS HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. ACCORDING TO INFORMATION RECEIVED ¿THE EVENT WAS REPORTED THROUGH A CLINICAL TRIAL, AND THE NEXT TIME WE GET DATA ON THIS PATIENT WILL BE AROUND (B)(6) 2016, THE EARLIEST¿. BASED ON THE LIMITED INFORMATION GIVEN THE REAL ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, THE MOST PRECISE EVALUATION REGARDING THE ROOT CAUSE OF PAIN IN THOSE CASES IS PROVIDED BY THE ABOVE CLINICAL ASSESSMENT. REVIEW OF DEVICE HISTORY RECORDS, COMPLAINT HISTORY AND CAPA DATABASES WAS DEEMED UNNECESSARY, SINCE NO PRODUCT FAILURE / MALFUNCTION WAS REPORTED. NO NONCONFORMITY WAS IDENTIFIED.

    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 REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PAIN IN RIGHT ANKLE MEDIAL GUTTER, TREATED WITH 4CC KENALOG 10 MIXED WITH 1% LIDOCAINE INJECTION.

    Description of Event or Problem · 1

    PAIN IN RIGHT ANKLE MEDIAL GUTTER, TREATED WITH 4CC KENALOG 10 MIXED WITH 1% LIDOCAINE INJECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427455 TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH (MDR) 130418/1899

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention