BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R E-CROSS

    MDR report key: 15258797 · Received August 19, 2022

    Report

    Report Number
    3005180920-2022-00620
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 20, 2022
    Report Date
    August 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261884
    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 18-AUG-2022 ON LOT 2012397: LOT 2012397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2021. EXPIRATION DATE: 2026-01-14. 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 IMPLANTED COMPONENTS: BATCH REVIEW PERFORMED ON 18-AUG-2022 ON GMK-SPHERE 02.12.KA15R FEMORAL COMPONENT SPHERIKA CEMENTED S5+R (K211004) LOT. 2113677. LOT 2113677: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2021. EXPIRATION DATE: 2026-10-20. 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. BATCH REVIEW PERFORMED ON 18-AUG-2022 ON GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT. 2111929. LOT 2111929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-NOV-2021. EXPIRATION DATE: 2026-11-14. 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. BATCH REVIEW PERFORMED ON 18-AUG-2022 ON GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT. 2112781. LOT 2112781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2021. EXPIRATION DATE: 2026-11-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 4 MONTHS AFTER THE 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790010 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R E-CROSS KNEE TIBIAL INSERT E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0413FR 2012397 07630971261884

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention