BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

    MDR report key: 9698515 · Received February 12, 2020

    Report

    Report Number
    3005180920-2020-00035
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862410
    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 ON 16 JANUARY 2020. LOT 184193: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2018. EXPIRATION DATE: 2023-09-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE COMPLAINT, BATCH REVIEW PERFORMED ON (B)(6) 2020. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 182891. LOT 182891: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2018. EXPIRATION DATE: 2023-09-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L (K121416) LOT. 183024. LOT 183024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2018. EXPIRATION DATE: 2023-07-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN CEMENTED TKA, 11 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER ALMOST 1 YEAR AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161827 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0025L 184193 07630030862410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention