BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

    MDR report key: 8073330 · Received November 15, 2018

    Report

    Report Number
    3005180920-2018-00904
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 15, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862618
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2018: LOT 143217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 SEPTEMBER 2014. EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    INFECTION FOLLOWED BY A LINER EXCHANGE OF A GMK-SPHERE KNEE 1 MONTH AFTER PRIMARY SURGERY. THE LINER WAS CHANGED WITH A NEW ONE OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913873 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 143217 07630030862618

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention