BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALAR COMP,SINGLE COATED US VERS MEDIUM, RIGHT

    MDR report key: 5308568 · Received December 17, 2015

    Report

    Report Number
    0008031020-2015-00505
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    May 18, 2011
    Report Date
    March 4, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 TALAR COMPONENT: MEDIUM (36MM X 35MM), RIGHT. WITH GUIDANCE FROM THE MDR POLICY BRANCH OF THE FDA, MDR REPORTED BY STRYKER GMBH, (B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM (B)(4). THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY (B)(4)., (B)(4) AND IMPLANTED PRIOR TO (B)(4) 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.

    Additional Manufacturer Narrative · 1

    ALL IMPLANTS WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE IMPLANTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THE STUDY RECORDS INCLUDED THAT BONE CYSTS WERE DETECTED AFTER ~4 YEARS AND THAT THE SLIDING CORE WITH LOT CODE ¿0314052¿ WAS EXCHANGED. 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 IMPLANT AND THE CYST CANNOT BE EXCLUDED. THE CASE REPRESENTS A RECURRING ISSUE FOR THE SLIDING CORE AND TALAR COMPONENT 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.

    Description of Event or Problem · 1

    RADIOLUCENCIES WERE DISCOVERED AFTER REVIEW ON THE TIBIAL SIDE OF IMPLANT. NO TREATMENT WAS PRESCRIBED.

    Description of Event or Problem · 1

    RADIOLUCENCIES WERE DISCOVERED AFTER REVIEW ON THE TIBIAL SIDE OF IMPLANT. NO TREATMENT WAS PRESCRIBED. REVISION SURGERY IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835934 TALAR COMP,SINGLE COATED US VERS MEDIUM, RIGHT PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 020123/1130

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other