BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L

    MDR report key: 14316012 · Received May 7, 2022

    Report

    Report Number
    3005180920-2022-00338
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 6, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2022. LOT 2104658: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2021. EXPIRATION DATE: 2026-JUN-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENT REVISED: GMK-SPHERE 02.07.0033RP PATELLA RESURFACING SIZE 1 (K090988) LOT. 2111889: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 2026-10-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY, PATELLA FRACTURE AND INFECTION DISCOVERED. INSERT REVISION AND OSTEOSYNTHESIS WITH TENSION BAND SUCCESSFULLY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534613 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L KNEE TIBIAL INSERT PE JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 2104658 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention