BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 3 R

    MDR report key: 8789420 · Received July 15, 2019

    Report

    Report Number
    3005180920-2019-00575
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    June 18, 2019
    Report Date
    October 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820205
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON THE (B)(6) 2019 WE WERE INFORMED THAT: ON THE (B)(6) 2019 THE SPACER HAS BEEN EXPLANTED AND THE FINAL HARDWARE HAVE BEEN IMPLANTED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 JUNE 2019: LOT 121833: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JULY-2012. EXPIRATION DATE: 2017-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES WERE INVOLVED IN THE EVENT. BATCH REVIEW PERFORMED ON 28 JUNE 2019: GMK-PRIMARY 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R LOT 121938 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AGO-2012. EXPIRATION DATE: 2017-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.0310FUC TIBIAL INSERT UC FIXED SIZE 3 / 10 MM LOT 121383 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2012. EXPIRATION DATE: 2017-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.0034RP PATELLA RESURFACING SIZE 2 LOT 122189 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-"AGO"-2012. EXPIRATION DATE: 2017-JUNE-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 6 YEARS AND 9 MONTHS AFTER PRIMARY REVISION SURGERY FOR INFECTION. ALL KNEE HARDWARE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584892 GMK-PRIMARY FEMUR STD CEMENTED SIZE 3 R KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 121833 07630030820205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention