BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 10389670 · Received August 11, 2020

    Report

    Report Number
    3005180920-2020-00529
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 11, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 10.08.2020: LOT 189124: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-FEB-2019. EXPIRATION DATE: 2024-01-27. 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. OTHER DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0022L FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L LOT. 1903616 (K140826). BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 10.08.2020: LOT 1903616: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-AUG-2019. EXPIRATION DATE: 2024-07-21. 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. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 LOT. 1906279 (K090988). BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 10.08.2020: LOT 1906279: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-SEP-2019. EXPIRATION DATE: 2024-09-02. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 6 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO HAVING A DISLOCATED PATELLA. DURING THE REVISION SURGERY, THE SURGEON REPAIRED THE QUAD TENDON BUT OBSERVED THAT FEMORAL COMPONENT WAS MISPLACED AND THE TIBIA WAS LOOSE. THE SURGEON DECIDED TO REMOVE ALL COMPONENTS AND IMPLANT A COMPETITOR'S KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853923 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1202L 189124 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention