BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 5 L

    MDR report key: 10222797 · Received July 2, 2020

    Report

    Report Number
    3005180920-2020-00363
    Event Type
    Injury
    Date Received
    July 2, 2020
    Date of Event
    May 29, 2020
    Report Date
    July 2, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820236
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 091256: 16 ITEMS MANUFACTURED AND RELEASED ON 24-JUN-2009. EXPIRATION DATE: 2014-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL ITEM INVOVLED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2020. GMK-PRIMARY 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 100385 LOT 100385: 31 ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2010. EXPIRATION DATE: 2015-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-PRIMARY 02.07.0510FUC TIBIAL INSERT UC FIXED SIZE 5 / 10 MM (K090988) LOT. 091789 LOT 091789: 24 ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2009. EXPIRATION DATE: 2014-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED FEMORAL COMPONENT, POLY AND TIBIAL TRAY 9 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687014 GMK-PRIMARY FEMUR STD CEMENTED SIZE 5 L FEMUR STD CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.2005L 091256 07630030820236

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention