BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    MDR report key: 10482597 · Received September 2, 2020

    Report

    Report Number
    3005180920-2020-00533
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    August 4, 2020
    Report Date
    September 2, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825866
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 13.08.2020: LOT 172741: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-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 OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT: GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT. 172921. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 13.08.2020: LOT 172921: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2017. EXPIRATION DATE: 2022-09-07. 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 02.12.0413FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R (K140826) LOT. 187260. BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2020: LOT 187260: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2018. EXPIRATION DATE: 2023-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT WITH ONE SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF A CLICKING NOISE AND INSTABILITY OF THE KNEE. THE SURGEON REVISED THE 10MM POLY WITH A 13MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN AND THE SURGEON TOOK POST-OP X-RAYS. THE SURGEON DECIDED TO REVISE THE PATIENT'S FEMORAL COMPONENT ((B)(6) 2020), TIBIAL TRAY, AND INSERT DUE TO A MISMATCHED FLEXION EXTENSION AND REMOVED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948835 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R FEMORAL KNEE COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0005R 172741 07630030825866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention