BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L

    MDR report key: 12631243 · Received October 14, 2021

    Report

    Report Number
    3005180920-2021-00806
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 17, 2021
    Report Date
    October 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825811
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29.09.2021: LOT 2010159: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-2020. EXPIRATION DATE: 2025-11-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 29.09.2021: GMK-SPHERE 02.07.0682L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 L (K123721) LOT 182075: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-JUN-2018. EXPIRATION DATE: 2023-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. GMK-SPHERE 02.09.TA205 TIBIAL AUGMENTATION SIZE 2/5MM (K130299) LOT 172049: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-MAY-2017. EXPIRATION DATE: 2022-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. GMK-SPHERE 02.09.TA205 TIBIAL AUGMENTATION SIZE 2/5MM (K130299) LOT 2000750: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2020. EXPIRATION DATE: 2025-02-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0214FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM L (K121416) LOT 168302: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2017. EXPIRATION DATE: 2022-01-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    4 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING LOOSENESS IN THE KNEE (LOOSE LIGAMENTS). THE SURGEON DECIDED TO CONVERT THE PATIENT TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535280 GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0003L 2010159 07630030825811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other