BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

    MDR report key: 10689620 · Received October 16, 2020

    Report

    Report Number
    3005180920-2020-00711
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862403
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 SEPTEMBER 2020: LOT 163347: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 2021-07-10. 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. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 166067. BATCH REVIEW PERFORMED ON 16 OCTOBER 2020: LOT 166067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2017. EXPIRATION DATE: 2022-01-01. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 3.5 YEARS AFTER PRIMARY CEMENTED TKA MOBILIZATION OF BOTH COMPONENT OCCURS. JUDGING FROM THE IMAGES RECEIVED, IT IS CONCEIVABLE THAT A PROBLEM WITH CEMENT OR CEMENTATION OCCURRED, AS NO RESIDUES OF CEMENT ARE VISIBLE ON EITHER EXPLANTED COMPONENT. MANY REASONS CAN AFFECT CEMENT INTERDIGITATION WITH THE METAL COMPONENTS, SUCH AS TEMPERATURES (OF THE OR AND/OR THE STORAGE ROOM), TIMING OF APPLICATION, WET SURFACES ET OTHERS. HOWEVER, A FINAL CONCLUSION ON THE CAUSES OF THIS REVISION CANNOT BE REACHED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: REVISION SURGERY AFTER 3 YEARS AND 6 MONTHS FROM PRIMARY FOR LOOSENING OF THE FEMORAL AND THE TIBIAL COMPONENT. LOOKING AT THE PICTURE OF THE EXPLANTED COMPONENTS, NO RESIDUAL CEMENT CAN BE SEEN ON THE DISTAL SURFACE OF THE TIBIA TRAY AND THE INTERNAL SURFACE OF THE FEMORAL COMPONENT. THIS IS COMMON FINDINGS ON EXPLANTED COMPONENTS EVEN IF THE CAUSE FOR REVISION IS NOT LOOSENING. SO, ABSENCE OF CEMENT ON EXPLANTED COMPONENTS IS NOT AN EVIDENCE OF A FAULTY DEVICE. MANY OTHER FACTORS (SUCH AS BONE QUALITY REDUCTION, OSTEOLYSIS, TRAUAMTIC EVENT), COULD HAD PLAYED A ROLE DURING TIME IN REDUCING PERFORMANCES OF INTERDIGITATION BETWEEN IMPLANT AND CEMENT ON BOTH TIBIAL AND FEMORAL SIDE. NO OTHER ASPECTS RELEVANT FOR THE EVENT CAN BE NOTED ON EXPLANTED COMPONENTS.

    Description of Event or Problem · 1

    TIBIAL AND FEMORAL LOOSENING. THE REASON IS UNKNOWN. REVISION SURGERY SUCCESSFULLY PERFORMED 3 YEARS AND 6 MONTHS AFTER PRIMARY SURGERY REMOVING FEMORAL AND INSERT COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157917 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0024R 163347 07630030862403

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention