BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALAR COMP,SINGLE COATED US VERS X-SMALL, LEFT

    MDR report key: 4869723 · Received June 25, 2015

    Report

    Report Number
    0008031020-2015-00256
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 29, 2015
    Manufacturer
    STRYKER GMBH (MDR)
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE TALAR COMPONENT AND THE SLIDING CORE WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR) FOR THE SLIDING CORE. THE SLIDING CORE WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. A DHR REVIEW FOR THE TALAR COMPONENT WAS NOT POSSIBLE DUE TO MISSING LOT CODE. AN INVESTIGATION OF THE TALAR COMPONENT WAS NOT POSSIBLE BECAUSE IT IS STILL IMPLANTED. THE EXPLANTED SLIDING CORE, PROVIDED TO THE EXTERNAL LAB EXPONENT, SHOWS NO VISIBLE DAMAGES. FURTHERMORE THE SURGEON STATED THAT THE IMPLANTS WERE NOT DAMAGED DURING REVISION. THEREFORE A MANUFACTURING ISSUE CAN BE EXCLUDED. THE REPORTED CYSTS COULD NOT BE CONFIRMED BECAUSE NO X-RAYS OR CT-SCANS WERE PROVIDED. ANYWAY, CYSTS WERE ALREADY EVALUATED BY A HCP IN THE STATEMENT ¿CLINICAL RESULTS OF THE STAR ANKLE PROSTHESIS, PAGE 70, 71¿: ¿CYST FORMATION (BONE RESORPTION) (0 ¿ 16 %) [1, 6, 9, 10, 12, 13, 15, 17, 20, 24, 27, 28, 30] SPONTANEOUS BONE RESORPTION AND CYST FORMATION REPRESENTS A SIGNIFICANT PROBLEM IN ANKLE ARTHROPLASTY. THE SYMPTOMS MAY BE MILD AND WILL NOT REQUIRE SPECIFIC SURGICAL MEASURES, BUT IN MANY CASES REVISION SURGERY WITH BONE GRAFTING MAY BE REQUIRED. IN ADVANCED CASES CYST FORMATION MAY CAUSE A COLLAPSE OF THE ARTHROPLASTY REQUIRING IMPLANT REMOVAL AND ANKLE FUSION.¿ ADDITIONALLY THE CASE WAS EVALUATED BY A PRODUCT EXPERT FROM THE DEVELOPMENT DEPARTMENT: ¿THIS IS A KNOWN COMPLICATION AND RISK IN THE SCIENTIFIC LITERATURE. THE EXACT SOURCE IS UNKNOWN. RESEARCHERS BELIEVE THAT IT IS DUE TO POLY WEAR DEBRIS AND/OR FLUID HYDRAULIC PRESSURE IN THE JOINT.¿ NEVERTHELESS, OSTEOLYSIS AND/OR OTHER PERIPROSTHETIC BONE LOSS (LIKE CYSTS) ARE ADVERSE EFFECTS AND MAY REQUIRE MEDICAL OR SURGICAL INTERVENTION (THEREFORE LISTED IN THE IFU). CONCLUSION: BASED ON THE EVALUATION A MANUFACTURING FAULT WAS NOT FOUND BUT A CORRELATION BETWEEN THE IMPLANTS AND THE FOUND CYSTS CANNOT BE EXCLUDED. THE CASE REPRESENTS A RECURRING ISSUE AND WILL BE MONITORED AND EVALUATED ACCORDING TO PMS TRENDING PROCEDURE DQI 13-004. DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW; NC#937715 WAS ALREADY INITIATED. NO OTHER NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT HAS DEVELOPED A BONE CYST UNDERNEATH THE TALAR COMPONENT. REVISION SURGERY IS JUNE 9TH.

    Description of Event or Problem · 1

    THE PATIENT HAS DEVELOPED A BONE CYST UNDERNEATH THE TALAR COMPONENT. REVISION SURGERY IS (B)(6). CYST IN TALUS; BONE QUALITY, GOOD. ANTERIOR INCISION WAS PERFORMED TO REMOVED CYST. TALAR AND TIBIAL COMPONENT WERE SOLID. JUST POLY SWAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412813 TALAR COMP,SINGLE COATED US VERS X-SMALL, LEFT PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH (MDR) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention