BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R

    MDR report key: 10156627 · Received June 16, 2020

    Report

    Report Number
    3005180920-2020-00335
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    May 18, 2020
    Report Date
    June 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862588
    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 REGULATORY AFFAIRS DEPARTMENT ON 3 JUNE 2020: LOT 1902497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-05-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED BY REGULATORY AFFAIRS DEPARTMENT ON 3 JUNE 2020: GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K121416) LOT. 1904585 LOT 1904585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-SEP-2019. EXPIRATION DATE: 2024-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 1906231 LOT 1906231: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-2019. EXPIRATION DATE: 2024-11-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE SBEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    HE PATIENT CAME IN REPORTING PAIN 4 MONTHS AFTER THE PRIMARY SURGERY AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND INSERT AND CONVERTED THE PATIENT TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622282 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R TIBIAL INSERT PS FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0311FR 1902497 07630030862588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention