BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

    MDR report key: 9523296 · Received December 27, 2019

    Report

    Report Number
    3005180920-2019-01097
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    December 4, 2019
    Report Date
    December 27, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825859
    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 16 DECEMBER 2019: LOT 179611: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2018. EXPIRATION DATE: 2023-07-27. 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. OTHER DEVICES INVOLVED IN THE EVENT GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L LOT. 180256 (K090988) BATCH REVIEW PERFORMED ON 16 DECEMBER 2019: LOT 180256: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2018. EXPIRATION DATE: 2023-MAY-08. 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. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 LOT. 155779 (K113571) BATCH REVIEW PERFORMED ON 16 DECEMBER 2019: LOT 155779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JAN-2016. EXPIRATION DATE: 2021-01-11. 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.

    Description of Event or Problem · 1

    ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON OBSERVED THAT ALL THE COMPONENTS WERE LOOSE AND THAT THE CEMENT DID NOT HOLD DURING THE PRIMARY SURGERY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, POLY, AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317469 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 179611 07630030825859

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention