BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R

    MDR report key: 10217919 · Received July 1, 2020

    Report

    Report Number
    3005180920-2020-00376
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826184
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 16 JUNE 2020: LOT 170315: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2017. EXPIRATION DATE: 2022-04-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION OF A GMK SPHERE PROSTHESIS 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO LAXITY (SPECIALLY IN FLEXION). THE SURGEON REVISED THE INLAY AND CHANGE TO A 14MM INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683665 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0212FR 170315 07630030826184

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention