BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    MDR report key: 18011665 · Received October 26, 2023

    Report

    Report Number
    3005180920-2023-00816
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826382
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 SEPTEMBER 2023: LOT 189044: (B)(1) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2019. EXPIRATION DATE: 2024-JAN-28. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 29 SEPTEMBER 2023: GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 2000629: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2025-FEB-24. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE PATELLA AND THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. ABOUT 3 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE PATELLA AND UPSIZED THE POLY (DUE TO INSTABILITY), AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000741 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 189044 07630030826382

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention