BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L

    MDR report key: 15867831 · Received November 28, 2022

    Report

    Report Number
    3005180920-2022-00894
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    January 23, 2018
    Report Date
    November 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825811
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15-NOV-2022: LOT 170242: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2017. EXPIRATION DATE: 2022-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 15-NOV-2022: GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L (K121416) LOT. 174783 LOT 174783: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2017. EXPIRATION DATE: 2022-09-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT. 170418: LOT 170418: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2017. EXPIRATION DATE: 2022-06-05. 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 THE REVIEW. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 173744: LOT 173744: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-SEP-2017. EXPIRATION DATE: 2022-08-31. 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 THE REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL THE IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2697131 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0003L 170242 07630030825811

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention