BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 17457135 · Received August 4, 2023

    Report

    Report Number
    3005180920-2023-00633
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    July 19, 2023
    Report Date
    August 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 JULY 2023. LOT 2011764: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2021. EXPIRATION DATE: 2026-MAR-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 26 JULY 2023: GMK-SPHERE 02.12.0006R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R (K121416) LOT 2101317: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2021. EXPIRATION DATE: 2026-APR-06. 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-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R (K140826) LOT 2012775: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2021. EXPIRATION DATE: 2026-FEB-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. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT 2001621: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-MAR-13. 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

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, 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
    1722432 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2011764 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention