BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL INSERT # 3/10 MM RIGHT

    MDR report key: 4963984 · Received July 29, 2015

    Report

    Report Number
    3005180920-2015-00154
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    October 28, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 28 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 27 OCTOBER 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6), 2015. LOT 133629: (B)(4) ITEMS MANUFACTURED AND RELEASED ON OCTOBER 14, 2013. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED PROBLEM. ON JULY 10, 2015, WE WERE INFORMED THAT THE X-RAYS AND THE IMPLANT ARE NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492654 GMK SPHERE TIBIAL INSERT # 3/10 MM RIGHT FIXED INSERT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1