BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 3

    MDR report key: 11918707 · Received June 2, 2021

    Report

    Report Number
    3005180920-2021-00454
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    April 20, 2021
    Report Date
    July 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815768
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: FEW MONTHS AFTER PRIMARY CEMENTED TKA A PARTIAL REVISION IS NECESSARY BECAUSE THE PATELLA LUXATES FROM THE TROCHLEA. THIS IS PROBABLY DUE TO THE ROTATIONAL POSITION OF THE FEMORAL COMPONENT. NO REASON TO SUSPECT A FAULTY DEVICE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 MAY 2021: LOT 2000632: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 27 MAY 2021: GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R (K121416) LOT 2003235: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2020. EXPIRATION DATE: 2025-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. MYSOLUTION ANALYSIS 01-JUN-2021: OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 1

    TKA PRIMARY SURGERY PERFORMED USING MYKNEE DEVICES FOR THE POSITIONING OF THE THE FEMORAL COMPONENT, TIBIAL TRAY AND THE RESURFACING PATELLA. NO ISSUE IN PER-OPERATIVE WAS NOTED THEN. A POST-OP CONTROL X-RAY INDICATED A DISLOCATION OF THE RESURFACING PATELLA AND A FEMORAL ROTATION OF 8¿. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 (6 MONTHS AFTER PRIMARY). ONLY THE FEMORAL COMPONENT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815362 GMK-SPHERE PATELLA RESURFACING SIZE 3 KNEE PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0035RP 2000632 07630030815768

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention