BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK

    MDR report key: 20680970 · Received November 14, 2024

    Report

    Report Number
    3005180920-2024-00935
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 17, 2024
    Report Date
    November 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261006
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 OCT 2024: LOT 2242111: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JAN-2023. EXPIRATION DATE: 2027-11-23. 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. GMK-SPHERIKA 02.12.E0512FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R E-CROSS (K202022) LOT 2245485: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEBR-2023. EXPIRATION DATE: 2028-01-25. 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.

    Description of Event or Problem · 0

    AT 1 YEAR AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND UPSIZED THE POLY (FROM 12 TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168505 GMK PATELLA RESURFACING SIZE 4 E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E004RP 2242111 07630971261006

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention