BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM L

    MDR report key: 12431527 · Received September 7, 2021

    Report

    Report Number
    3005180920-2021-00723
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    August 12, 2021
    Report Date
    September 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 AUGUST 2021: LOT 1901304: 74 ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. EXPIRATION DATE: 2024-MAY-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 73 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 19 AUGUST 2021: GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L (K121416) LOT 1811341: 42 ITEMS MANUFACTURED AND RELEASED ON 02-APR-2019. EXPIRATION DATE: 2024-MARCH-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K0909889) LOT 1902683: 67 ITEMS MANUFACTURED AND RELEASED ON 13-AUG-2019. EXPIRATION DATE: 2024-JULY-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 66 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL IMPLANTS TO COMPETITOR IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332228 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM L TIBIAL INSERT FIXED FLEX JWH MEDACTA INTERNATIONAL SA 02.12.0410FL 1901304 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention