BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SELZACH_PRODUCT

    MDR report key: 5272041 · Received December 7, 2015

    Report

    Report Number
    0008031020-2015-00475
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 10, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. UNKNOWN STAR TALUS COMPONENT. DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED ALL IMPLANTS TO BE PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEMS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. ALL STAR IMPLANTS WERE EXPLANTED; THE VISUAL INSPECTION REVEALED THAT THE IMPLANTS ARE NOT DAMAGED OR BROKEN. ACCORDING TO THE AVAILABLE INFORMATION THE STAR IMPLANTS WERE INCORRECT IMPLANTED IN (B)(6) 2013 LEADING TO AN IMPROPER POSITION. THEREFORE SEVERAL REVISIONS WERE PERFORMED I.E. EXCHANGING A SLIDING CORE IN (B)(6) 2015. FINALLY THE IMPLANTS WERE REMOVED TO RE-MODEL THE BONE SURFACES TO CORRECT THE POSITION. COMPETITOR IMPLANTS WERE IMPLANTED. THE IFU AND OPERATIVE TECHNIQUE INCLUDES THAT EVERY SURGEON / USER MUST BE TRAINED PRIOR USING THE STAR SYSTEM; PRE-OPERATIVE PLANNING IS ESSENTIAL TO GUARANTEE A CORRECT IMPLANT POSITION. FURTHERMORE THE CORRECT IMPLANT SIZE MUST BE CHOSEN CAREFULLY. PRE-OPERATIVE PLANNING AND SURGERY STEPS ARE EXPLAINED IN DETAIL. BASED ON THE GIVEN INFORMATION A MANUFACTURING ISSUE CAN BE EXCLUDED; THE REMOVAL DUE TO IMPROPER IMPLANT POSITIONS IS RELATED TO THE USER OF THE PRIMARY IMPLANTATION IN 2013. DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW; (B)(4) WAS ALREADY INITIATED. NO OTHER NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    PATIENT'S ANKLE IS UNSTABLE. INPROPER POSITIONING FROM THE PRIMARY SURGERY. ALL IMPLANTS ARE GETTING PULLED OUT AND SURGEON HAS TO DO A RECUT. WILL IMPLANT COMPETITOR PRODUCT AND USE THEIR STEM COMPONENT. DOING BONY WORK AS WELL TO HELP REPOSITION THE FOOT TO GET IT BACK IN LINE. NONE OF THE IMPLANTS ARE BROKEN. WAS INFORMED OF AN UPCOMING TOTAL ANKLE REVISION. INFORMED OF THE SURGICAL INTERVENTION PLAN TO REMOVE AND REPLACE TOTAL ANKLE. SCHEDULED SURGERY DATE IS (B)(6).

    Description of Event or Problem · 1

    PATIENT ANKLE IS UNSTABLE. INPROPER POSITIONING FROM THE PRIMARY SURGERY. ALL IMPLANTS ARE GETTING PULLED OUT AND SURGEON HAS TO DO A RECUT. WILL IMPLANT COMPETITOR PRODUCT AND USE THEIR STEM COMPONENT. DOING BONY WORK AS WELL TO HELP REPOSITION THE FOOT TO GET IT BACK IN LINE. NONE OF THE IMPLANTS ARE BROKEN. AS INFORMED OF AN UPCOMING TOTAL ANKLE REVISION. INFORMED OF THE SURGICAL INTERVENTION PLAN TO REMOVE AND REPLACE TOTAL ANKLE. SCHEDULED SURGERY DATE IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803211 UNKNOWN_SELZACH_PRODUCT PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention