BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL INSERT SIZE 4 / 14 MM

    MDR report key: 5236525 · Received November 19, 2015

    Report

    Report Number
    3005180920-2015-00268
    Event Type
    Injury
    Date Received
    November 19, 2015
    Date of Event
    October 19, 2015
    Report Date
    November 19, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 NOVEMBER 2015: LOT 123219: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 NOVEMBER 2012. EXPIRATION DATE: 2017-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR CASE ((B)(4)). ON 18 NOV 2015 IT WAS CONFIRMED THAT THE SALES AGENT WAS NOT ABLE TO GET THE PATHOLOGY RESULTS. ON 19 NOV 15 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ABOVE REPORTED. ON THE SAME DAYS IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN IN HER RIGHT KNEE. THE SURGEON DECIDED TO SWAP THE POLY INSERT ALONG WITH AN IRRIGATION AND DEBRIDEMENT OF THE KNEE. EXPLANTS WILL NOT BE RETURNED. AVAILABILITY OF PATHOLOGY IS PENDING. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764995 GMK SPHERE TIBIAL INSERT SIZE 4 / 14 MM PE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 123219

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention