BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L

    MDR report key: 16743198 · Received April 14, 2023

    Report

    Report Number
    3005180920-2023-00257
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    March 17, 2023
    Report Date
    May 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 5 YEARS AFTER PRIMARY CEMENTED TKA THE COMPONENTS MOBILIZE AND REQUIRE REVISION SURGERY. THE REPORT DOES NOT MENTION A TRAUMATIC EVENT, ALTHOUGH THE MASSIVE MOBILIZATION OF THE TIBIAL COMPONENT AND THE CONTEMPORARY MOBILIZATION OF THE FEMUR LEAD TO SUSPECT THAT SOME TRIGGERING EPISODE MAY HAVE HAPPENED. HOWEVER, THIS CASE SHOULD BE CATEGORIZED AS ASEPTIC LOOSENING AND WE SEE NO REASON TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE AS THE MAIN RESPONSIBLE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 MARCH 2023: LOT 180945: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2018. EXPIRATION DATE: 2023-04-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 23 MARCH 2023 ON GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 (K121416) L LOT. 180376. LOT 180376: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2018. EXPIRATION DATE: 2023-04-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 4 YEARS AND 8 MONTHS POST PRIMARY DUE TO THE CEMENTED FEMUR AND TIBIA DEVICES LOOSENING. ALL DEVICES WERE SWAPPED SUCCESSFULLY. GRANULOMAS WERE PRESENT IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392316 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L KNEE CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0004L 180945 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention