BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    MDR report key: 11633271 · Received April 8, 2021

    Report

    Report Number
    3005180920-2021-00283
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 MARCH 2021: LOT 1901307: 74 ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2019. EXPIRATION DATE: 2024-04-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 71 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0007L FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L (K121416) LOT. 1901831 BATCH REVIEW PERFORMED ON 17 MARCH 2021: LOT 1901831: 47 ITEMS MANUFACTURED AND RELEASED ON 14-JUNE-2019. EXPIRATION DATE: 2024-05-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 33 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 1902691 BATCH REVIEW PERFORMED ON 17 MARCH 2021: LOT 1902691: 30 ITEMS MANUFACTURED AND RELEASED ON 30-JUL-2019. EXPIRATION DATE: 2024-07-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER ONE YEAR AND A HALF FROM PRIMARY DUE TO PAIN AND STIFNESS. SURGEON NOTICED LACK OF CEMENT ON EXPLANTED COMPONENTS. LOOSENING OR MOBILIZATION OF THE IMPLANTS HAVE NOT BEEN REPORTED. FROM THE PICTURES SENT OF THE REVISED COMPONENTS, WE CAN NOTICE THAT NO RESIDUAL CEMENT CAN BE SEEN ON THE DISTAL SURFACE OF THE TIBIAL TRAY; SOME RESIDUAL CEMENT CAN BE SEEN IN THE INNER DISTAL PLANE OF THE FEMORAL COMPONENT. ABSCENCE OF CEMENT IS SOMETHING USUAL TO BE SEEN ON EXPLANTED COMPONENTS, EVEN IF THE CAUSE FOR REVISION WAS NOT LOOSENING OR MOBILIZATION. THIS IS NOT AN EVIDENCE OF POOR INTERDIGITATION BETWEEN CEMENT AND IMPLANT. CAUSE FOR PAIN AND STIFFNESS REMAIN UNKNOWN. THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE. PATIENT MATCH PLANNING REVIEW PERFORMED BY MY SOLUTION DEPARTMENT OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 1

    REVISION SURGERY 1 YEAR AND 5 MONTHS AFTER PRIMARY FOR KNEE PAIN AND STIFFNESS. THE SURGEON DIDN'T FOUND SIGNS OF CEMENT ON THE BACKSIDE OF THE IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531949 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FL 1901307 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention