BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 8615721 · Received May 16, 2019

    Report

    Report Number
    3005180920-2019-00378
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 16, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 MAY 2019: LOT 182907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2018. EXPIRATION DATE: 2023-09-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT ADDITIONAL IMPLANTS INVOLVED: GMK-SPHERE 02.12.0025R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R (K140826), LOT 181864: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2018. EXPIRATION DATE: 2023-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988), LOT 185029: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2018. EXPIRATION DATE: 2023-09-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416), LOT 184903: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2018. EXPIRATION DATE: 2023-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D KNEE MANAGER: PICTURES ARE RELATED TO THE EXPLANTED FEMORAL COMPONENT AND CEMENT REMOVED FROM THE FEMUR BONE. REVISION SURGERY DUE TO INFECTION. WE HAVE NO REASONS TO THINK THAT THE EVENT IS SOMEHOW RELATED TO THE IMPLANTS. NO FURTHER CONSIDERATIONS CAN BE DONE ON THE PICTURE OF THE EXPLANTED FEMORAL COMPONENT AND THE CEMENT REMOVED FROM THE FEMUR.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON THE NEXT DAY DUE TO INFECTION, 3 MONTHS AFTER PRIMARY, ALL COMPONENTS HAVE BEEN REMOVED. PATHOGEN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411579 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 182907 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention