BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

    MDR report key: 10282359 · Received July 16, 2020

    Report

    Report Number
    3005180920-2020-00421
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    June 19, 2020
    Report Date
    July 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862403
    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 ON 13 JULY 2020: LOT 181862: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUL-2018. EXPIRATION DATE: 2023-06-14. 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 IMPLANT INVOLVED: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416) LOT. 181897 BATCH REVIEW PERFORMED ON 13 JULY 2020: LOT 181897: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUN-2018. EXPIRATION DATE: 2023-05-13. 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. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416) LOT. 172762 BATCH REVIEW PERFORMED ON 13 JULY 2020: LOT 172762: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEPT-2017. EXPIRATION DATE: 2022-08-29. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR 1,5 YEARS AFTER PRIMARY CEMENTED TKA THE WHOLE SYSTEM IS REVISED BECAUSE THE PATIENT CANNOT GET GOOD FLEXION. THIS IS DUE TO THE POSITION OF THE TIBIA, SHOWN ON THE PRE-REVISION XRAY TO HAVE ANTERIOR SLOPE. WE CANNOT TELL IF THIS WAS THE SITUATION POSTOPERATIVELY, DUE TO A CHOICE OF THE SURGEON, OR THE COMPONENT MIGRATED, FOR UNKNOWN REASONS. THE CAUSE FOR REVISION IS TIBIA POSITION. NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING AN INABILITY TO ACHIEVE FULL FLEXION DUE TO NEGATIVE SLOPE IN THE TIBIA. THE REASON OF SLOPE UNKNOWN. 1 YEAR AND 7 MONTHS AFTER PRIMARY THE SURGEON REVISED ALL MEDACTA IMPLANTS AND REPLACED THEM WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749049 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0024R 181862 07630030862403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention