BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20681572 · Received November 14, 2024

    Report

    Report Number
    3005180920-2024-00931
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826580
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22-OCT-2024. LOT 2012708: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2021. EXPIRATION DATE: 2026-01-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 22-OCT-2024. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 2100297: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-03-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. WHILE REGARDING THE PATELLA PAIN, BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. 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

    AT ABOUT 3 YEARS AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PATELLA PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA IMPLANT AND REVISED THE INSERT (12MM) WITH A THICKER ONE (14MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195139 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R JWH MEDACTA INTERNATIONAL SA 02.12.0412FR 2012708 07630030826580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention