BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

    MDR report key: 10282570 · Received July 16, 2020

    Report

    Report Number
    3005180920-2020-00425
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    June 21, 2020
    Report Date
    July 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820885
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 3 JULY 2020 LOT 134734: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2013. EXPIRATION DATE: 2018-10-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. OTHER DEVICES INVOLVED IN THE EVENT GMK-PRIMARY 02.07.0510APPS FULL-PE PS TIBIAL COMPONENT #5/10 LOT. 154056 (K131310) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 3 JULY 2020 LOT 154056: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-NOV-2015. EXPIRATION DATE: 2020-11-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-PRIMARY 02.07.0035RP PATELLA RESURFACING # 3 LOT. 173028 (K090988) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 3 JULY 2020 LOT 173028: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-SEP-2017. EXPIRATION DATE: 2022-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 118 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.0510APPS FULL-PE PS TIBIAL COMPONENT #5/10 LOT. 124456 (K131310) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 3 JULY 2020 LOT 124456: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 6-SEP-2013. EXPIRATION DATE: 2017-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-PRIMARY 02.07.2206R FEMUR PS CEMENTED # 6 R LOT. 133888 (K090988) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 3 JULY 2020 LOT 133888: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-OCT-2013. EXPIRATION DATE: 2018-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-PRIMARY 02.07.0035RP PATELLA RESURFACING # 3 LOT. 140229 (K090988) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 3 JULY 2020 LOT 140229: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 120 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 2 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION IN BOTH KNEES AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED BILATERAL WASHOUT AND REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747925 GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L FEMUR PS CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.2206L 134734 07630030820885

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention