BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R

    MDR report key: 9989994 · Received April 23, 2020

    Report

    Report Number
    3005180920-2020-00251
    Event Type
    Injury
    Date Received
    April 23, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 23, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862670
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 6 APRIL 2020: LOT 180415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2018. EXPIRATION DATE: 2023-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0006R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R (K121416) LOT. 1901857. BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 6 APRIL 2020: LOT 1901857: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 1903518. BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 6 APRIL 2020: LOT 1903518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2019. EXPIRATION DATE: 2024-09-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 1903586. BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 6 APRIL 2020: LOT 1903586: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 2024-06-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 5 MONTHS FROM THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED SPACER WITH ANTIBIOTIC CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454956 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0513FR 180415 07630030862670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention