BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 11054056 · Received December 22, 2020

    Report

    Report Number
    3005180920-2020-00935
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    October 1, 2019
    Report Date
    December 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 7 DECEMBER 2020: LOT 1811591: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2019. EXPIRATION DATE: 2024-04-14. 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: ABOUT 1 YEAR AFTER PRIMARY CEMENTED TKA, INSTABILITY OF THE JOINT REQUIRES A CONSTRAINED PROSTHESIS TO BE IMPLANTED. THIS IS NOT DUE TO FAILURE OF FORMER DEVICE BUT TO DISEASE PROGRESSION. PRELIMINARY INVESTIGATION: ABOUT 1 YEAR AFTER PRIMARY CEMENTED TKA, INSTABILITY OF THE JOINT REQUIRES A CONSTRAINED PROSTHESIS TO BE IMPLANTED. WITH REFERENCE TO THE PICTURES OF THE EXPLANTED COMPONENT, NO RESIDUAL CEMENT CAN BE OBSERVED ON THE DISTAL SURFACE OF THE TIBIA TRAY. AT THE TIME OF THE SURGERY, THE TIBIAL COMPONENT WAS WELL CONNECTED TO THE BONE. THE ABSENCE OF CEMENT ON EXPLANTED COMPONENTS IS NOT EVIDENCE OF A FAULTY DEVICE. MANY OTHER FACTORS (SUCH AS BONE QUALITY REDUCTION, OSTEOLYSIS, TRAUMATIC EVENT), COULD HAVE PLAYED A ROLE IN REDUCING PERFORMANCES OF INTERDIGITATION BETWEEN IMPLANT AND CEMENT. NO FURTHER CONSIDERATION CAN BE DRAWN WITH THE PICTURES AT HAND.

    Description of Event or Problem · 1

    ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY OPERATION, THE PATIENT DEVELOPED MASSIVE BANDISTABILITY, WHICH MADE THE INDICATION TO SWITCH TO A GMK HINGE SYSTEM. WHEN THE IMPLANTS WERE EXPLANTED, BOTH THE FEMUR AND THE TIBIA WERE WELL CONNECTED TO THE BONE. WHEN WORKING ON THE TIBIA WITH A LAMBOTTE CHISEL, THE TIBIA HAS BECOME COMPLETELY DETACHED FROM THE CEMENT. IT IS SUSPECTED THAT THE TIBIAL COMPONENT WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520171 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1205R 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention