BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 1 E-CROSS

    MDR report key: 18612968 · Received January 31, 2024

    Report

    Report Number
    3005180920-2024-00014
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 31, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971260979
    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 11-JAN-2024 LOT 2012664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2021. EXPIRATION DATE: 2025-12-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 11-JAN-2024 GMK-SPHERE 02.12.0004R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R (K121416) LOT 2244557: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-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 CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.E0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS (K202022) LOT 2241318: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416) LOT 2300367: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2023. EXPIRATION DATE: 2028-04-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383355 GMK-SPHERE PATELLA RESURFACING SIZE 1 E-CROSS KNEE PATELLA RESURFACING JWH MEDACTA INTERNATIONAL SA 2012664 07630971260979

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention