BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX #4/10 MM L

    MDR report key: 7120558 · Received December 15, 2017

    Report

    Report Number
    3005180920-2017-00741
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 15, 2017
    Report Date
    December 15, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 DECEMBER 2017: LOT 162283: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 JULY 2016. EXPIRATION DATE: 2021-06-22.. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF LAXITY. THE SURGEON DETERMINED THE TISSUE HAD LOOSENED. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGERY REVISED THE INSERT FROM A 10MM TO A 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899742 GMK-SPHERE TIBIAL INSERT FIXED FLEX #4/10 MM L FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 162283 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention