BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

    MDR report key: 10875437 · Received November 20, 2020

    Report

    Report Number
    3005180920-2020-00814
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 20, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827143
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 OCTOBER 2020: LOT 171842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-LUL-2017. EXPIRATION DATE: 2022-07-16. 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: LOOSENING OF TIBIAL BASEPLATE IN A CEMENTED TKA PERFORMED TWO YEARS BEFORE. THE EXPLANTED DEVICES HAD BEEN IMPLANTED AS REVISION OF PREVIOUS SIMILAR COMPONENTS. NO INDICATION OF A DEFECT IN THE PROCEDURE IS VISIBLE ON THE XRAYS. ASEPTIC LOOSENING IS A POSSIBLE ADVERSE EVENT FOLLOWING TKA, DESCRIBED IN LITERATURE. NO EVIDENCE OF A DEVICE DEFECT. THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. OTHER DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0412FR GMK-SPHERE TIBIAL INSERT - FLEX S4R - 12 MM LOT. 174808 (K121416) BATCH REVIEW PERFORMED ON 15 OCTOBER 2020. LOT 174808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2017. EXPIRATION DATE: 2022-07-19. 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.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY PERFORMED AFTER 5 MONTHS FROM THE PREVIOUS REVISION SURGERY DUE TO THE MOBILIZATION OF THE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY, THE LINER AND THE PATELLA IMPLANT. DURING THE FIRST REVISION SURGERY PERFORMED AFTER 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER FROM 12 MM(LOT 174808) TO 17 MM (LOT 154783) AND ADD THE PATELLA IMPLANT DUE TO KNEE INSTABILITY AND PATELLAR CHONDROPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344604 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.T3I4R 171842 07630030827143

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention