BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22008320 · Received May 13, 2025

    Report

    Report Number
    3005180920-2025-00400
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 13, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261327
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17-04-2025: LOT 2427168: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-10-2024. EXPIRATION DATE: 2029-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 17-04-2025: GMK-SPHERIKA 02.12.KA03R FEMORAL COMPONENT SPHERIKA CEMENTED S3R (K211004) LOT 2428527: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-12-2024. EXPIRATION DATE: 2029-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT REVISION AT ABOUT 1 WEEK FROM PRIMARY AFTER REPORTING PAIN DUE TO DISLOCATING HER LEG WHILE STILL IN THE HOSPITAL FROM THE PRIMARY SURGERY. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. SEVERE LIGAMENT LAXITY WAS REPORTED AND POSTERIOR CAPSULE WAS COMPROMISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184925 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0211FR 2427168 07630971261327

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention