BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L

    MDR report key: 17215115 · Received June 28, 2023

    Report

    Report Number
    3005180920-2023-00406
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    May 30, 2023
    Report Date
    June 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820212
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    GMK-PRIMARY 02.07.2004L FEMUR STD CEMENTED SIZE 4 L LOT. 120962. LOT 120962: (B)(4) MANUFACTURED AND RELEASED ON 11-MAY-2012. EXPIRATION DATE: 2017-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2023. GMK-PRIMARY 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 121109. LOT 121109: (B)(4) MANUFACTURED AND RELEASED ON 23-MAY-2012. EXPIRATION DATE: 2017-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT. 121137. LOT 121137: (B)(4) MANUFACTURED AND RELEASED ON 30-MAY-2012. EXPIRATION DATE: 2017-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 10 YEARS AND 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE LOOSENING OF FEMORAL AND PATELLA IMPLANTS AND SUBSIDENCE OF TIBIAL COMPONENT. THE CAUSE IS UNKNOWN. THE SURGEON REVISED TO REVISION SYSTEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168421 GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L KNEE STANDARD FEMUR JWH MEDACTA INTERNATIONAL SA 02.07.2004L 120962 07630030820212

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention