BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 RIGHT

    MDR report key: 5822607 · Received July 26, 2016

    Report

    Report Number
    3005180920-2016-00392
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    July 6, 2016
    Report Date
    December 15, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 13 JULY 2016 FROM THE INITIAL REPORTER AND INCLUDES: THE REVISION SURGERY HAS BEEN POSTPONED ON (B)(6) 2016. ON (B)(6) 2016, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: THREE YEARS AFTER PRIMARY CEMENTED TKA THE TIBIAL BASE IS CONSIDERED RADIOGRAPHICALLY LOOSE. MALE, HEAVY PATIENT. IN THE SAGITTAL VIEW, THE SLOPE OF THE TIBIAL COMPONENT APPEARS VERY PRONOUNCED, PARTICULARLY FOR A POSTERIORLY STABILIZED IMPLANT. THIS MAY BE RELEVANT FOR THE SUBSEQUENT LOOSENING, BUT NO CONCLUSION CAN BE DRAWN. BATCH REVIEW PERFORMED ON 22 JULY 2016. LOT 132751: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 AUGUST 2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 18 NOVEMBER 2016 AND INCLUDES: THE PATIENT FEELS WELL AND WON'T GET OPERATED.

    Description of Event or Problem · 1

    AFTER THE PRIMARY SURGERY, THE PATIENT HAS NEVER GONE WELL, HE ALWAYS HAD PAIN AND GOT PROBLEMS TO WALK. A REVISION HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475719 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 RIGHT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 132751

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention