BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L

    MDR report key: 13222353 · Received January 11, 2022

    Report

    Report Number
    3005180920-2022-00009
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    December 16, 2021
    Report Date
    January 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862397
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 DECEMBER 2021. LOT 171808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2017. EXPIRATION DATE: 2022-JUN-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT. 171944. BATCH REVIEW PERFORMED ON 17 DECEMBER 2021. LOT 171944: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2017. EXPIRATION DATE: 2022-JUN-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 1 YEAR FROM PRIMARY IMPLANTATION FOR LOOSENING OF THE TIBIA COMPONENT. FROM PICTURES OF THE EXPLANTED COMPONENT, NO RESIDUAL CEMENT CAN BE IDENTIFIED ON THE DISTAL SURFACE OF THE TIBIA TRAY. SURFACE FINISHING OF THE TIBIA BASEPLATE SEEMS TO BE IN COMPLIANCE WITH THE SPECIFICATIONS REQUIRED. LACK OF ADHESION BETWEEN THE CEMENT AND THE IMPLANT IS NOT AN EVIDENCE OF A FAULTY DEVICE. POOR CEMENT INTER-DIGITATION ON THE IMPLANT SURFACE ARE OF VARIOUS ORIGIN; THEY COULD BE RELATED TO THE CEMENT AND CEMENTATION PROCEDURE OR MOBILIZATION OF THE IMPLANT DURING CURING. FROM PRELIMINARY INVESTIGATION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ABOUT 1 YEAR AND 1 MONTH DUE TO TIBIAL AND FEMORAL COMPONENT LOOSENING. THE SURGEON COMMENTED THAT NO CEMENT WAS ATTACHED TO FEMORAL AND TIBIAL IMPLANTS IMPLANTED IN PRIMARY SURGERY AND THAT IMPLANT FIXATION IS POOR. ALL COMPONENTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961265 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0024L 171808 07630030862397

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention