BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM

    MDR report key: 15527285 · Received October 3, 2022

    Report

    Report Number
    3005180920-2022-00743
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 3, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817717
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 OCTOBER 2022: LOT 104103: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2011. EXPIRATION DATE: 2015-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 03 OCTOBER 2022: GMK-PRIMARY 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 103391: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2010. EXPIRATION DATE: 2015-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 11 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (12 TO 14 MM) AND REVISED THE PATELLA IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315120 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0412FUC 104103 07630030817717

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention