BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L

    MDR report key: 12353121 · Received August 23, 2021

    Report

    Report Number
    3005180920-2021-00674
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    July 26, 2021
    Report Date
    August 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862656
    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 JULY 2021. LOT 151945: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-JULY-2015. EXPIRATION DATE: 2020-MAY-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT SINCE 2017. OTHER COMPONENTS INVOLVED: GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED # 5 L LOT. 186106 K121416. LOT 186106: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2018. EXPIRATION DATE: 2023-OCT-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED # 5 L LOT. 186201 K090988. LOT 186201: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2018. EXPIRATION DATE: 2023-OCT-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE OF BOTH THE PAIN AND INSTABILITY IS UNKNOWN. THE SURGEON DECIDED TO GIVE THE PATIENT A FULL REVISION AND REVISE THE FEMUR, TIBIA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250246 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0513FL 151945 07630030862656

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention