BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM

    MDR report key: 19623608 · Received June 27, 2024

    Report

    Report Number
    3005180920-2024-00453
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816932
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 JUNE 2024: LOT 189528: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2018. EXPIRATION DATE: 2023-12-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: 2.5 YEARS AFTER REVISION TKA, THE PATELLA DISLOCATED LATERALLY AND THE KNEE WAS PAINFUL. ACCORDING TO REPORT, A PROBABLE CAUSE FOR THIS DISLOCATION WAS SUBOPTIMAL ORIENTATION OF THE COMPONENTS; IN FACT, IN ORDER TO SOLVE THE PROBLEM, THE SURGEON DECIDED TO EXPLANT THE FORMER DEVICES AND REPOSITION NEW ONES, WITH NEW BONE CUTS. A SECONDARY LAXITY OF THE MEDIAL COLLATERAL LIGAMENT PROBABLY CONTRIBUTED TO THE POOR OUTCOME PERCEIVED BY THE PATIENT. NEITHER OF THE SITUATIONS SEEMS TO BE ATTRIBUTABLE TO A DEFECTIVE DEVICE. ADDITIONAL REVISED IMPLANTS: BATCH REVIEW PERFORMED ON 27 JUNE 2024 ON GMK-REVISION 02.07.0682R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R (K123721) LOT. 184299. LOT 184299: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2018. EXPIRATION DATE: 2023-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 27 JUNE 2024 ON GMK-REVISION 02.07.2403R FEMUR REVISION PS SIZE 3 R (K102437) LOT. 1904774. LOT 1904774: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2019. EXPIRATION DATE: 2024-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS 6 MONTHS AFTER THE MEDACTA PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATING COMPETITOR'S PATELLA IMPLANT AND A VERY LOOSE MEDIAL COLLATERAL LIGAMENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT FROM GMK-REVISION TO GMK- HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442621 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 189528 07630030816932

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention