BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L

    MDR report key: 8073329 · Received November 15, 2018

    Report

    Report Number
    3005180920-2018-00902
    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
    07630030826573
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2018: LOT 161370: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MAY 2016. EXPIRATION DATE: 2021-05-12. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF LAXITY 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED A 12MM POLY FOR A 14MM POLY. DURING SURGERY THE PATELLA WAS KNOCKED LOOSE SO IT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913871 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 161370 07630030826573

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention