BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 18301127 · Received December 11, 2023

    Report

    Report Number
    3005180920-2023-00938
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    November 13, 2023
    Report Date
    December 11, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2023: LOT 168767: (B)(4) MANUFACTURED AND RELEASED ON 28-MAR-2017. EXPIRATION DATE: 2022-03-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 48 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 14 NOVEMBER 2023. GMK-SPHERE 02.12.0211FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R (K140826) LOT 166511:(B)(4) MANUFACTURED AND RELEASED ON 13-DEC-2016. EXPIRATION DATE: 2021-11-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 71 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT 160577: (B)(4)MANUFACTURED AND RELEASED ON 23-MAR-2016. EXPIRATION DATE: 2021-03-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 6 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS IDENTIFIED AS MRSA. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845708 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 168767 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention