BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R

    MDR report key: 10137534 · Received June 10, 2020

    Report

    Report Number
    3005180920-2020-00318
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030807893
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 MAY 2020: LOT 176556: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2018. EXPIRATION DATE: 2022-12-18. 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 DEVICE INVOLVED IN THE EVENT: GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED # 4 R LOT. 182908 (K090988) BATCH REVIEW PERFORMED ON 25 MAY 2020: LOT 182908: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEPT-2018. EXPIRATION DATE: 2023-09-18. 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

    THE PATIENT COMPLAINED PAIN AND INSTABILITY. IT WAS NOTICED THAT THERE WAS NO BONDING BETWEEN THE CEMENT AND THE FEMORAL AND TIBIAL IMPLANT. THE CEMENT IN PLACE WAS FROM COMPETITOR. 1 YEAR AND 1 MONTH AFTER PRIMARY THE REVISION SURGEON REVISED ALL THE IMPLANTS SUCCESSFULLY AND STATED THAT THE FEMUR IMPLANT WAS OVERSIZED FOR THE PATIENT KNEE. PRIMARY SURGEON WAS NOT THE REVISION SURGEON. A HINGE COMPETITOR SYSTEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604573 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 01.26.45.1152 07630030807893

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention