BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #3/13 MM R

    MDR report key: 8644139 · Received May 27, 2019

    Report

    Report Number
    3005180920-2019-00419
    Event Type
    Injury
    Date Received
    May 27, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 27, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862595
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 MAY 2019: LOT 141417: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF ANTERIOR KNEE PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON RESURFACED THE PATELLA AND REVISED THE POLY 2 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437745 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #3/13 MM R KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141417 07630030862595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention