BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR PS SIZE 2 R

    MDR report key: 11307782 · Received February 10, 2021

    Report

    Report Number
    3005180920-2021-00090
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    January 11, 2021
    Report Date
    February 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821394
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08-FEB-2021: LOT 1900611: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-JUN-25. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: 1.25 YEARS AFTER REVISION KNEE ARTHROPLASTY, THE KNEE BECOMES UNSTABLE BECAUSE OF INSUFFICIENCY OF COLLATERAL LIGAMENTS. THIS CONDITION REQUIRES A CONSTRAINED DEVICE TO BE USED; THE IMPLANTED COMPONENTS ARE THEREFORE REMOVED. IT IS SUPPOSEDLY DUE TO DISEASE PROGRESSION AND NOT TO A DEFECTIVE DEVICE. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 08-FEB-2021: GMK-REVISION 02.07.0212, SCF FIXED TIBIAL INSERT SC SIZE 2/12MM (K103170) LOT. 1904791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2019. EXPIRATION DATE: 2024-JUL-09. 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. BATCH REVIEW PERFORMED ON 08-FEB-2021: GMK-REVISION 02.07.0682R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R (K123721)LOT. 1902918: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-SEP-17. 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.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO LATERAL AND MEDIAL INSTABILITY 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY. GMK-REVISION WAS REPLACED WITH A GMK-HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202977 GMK-REVISION FEMUR PS SIZE 2 R KNEE PROSTEHESIS FEMORAL IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.2402R 1900611 07630030821394

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention