BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    MDR report key: 17823868 · Received September 27, 2023

    Report

    Report Number
    3005180920-2023-00742
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01-SEP-2023. LOT 2119173: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-APR-2022. EXPIRATION DATE: 2027-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0021R FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R (K140826) LOT 2103456: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2021. EXPIRATION DATE: 2026-05-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.E0212FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS (K202022) LOT 2105597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2021. EXPIRATION DATE: 2026-06-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND DISCOMFORT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR, INSERT AND TIBIAL TRAY WITH REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ANY ISSUE WITH THE IMPLANTS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096956 GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 2119173 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention