BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR CEMENTED PS SIZE 4NARROW / RIGHT

    MDR report key: 8909365 · Received August 20, 2019

    Report

    Report Number
    3005180920-2019-00691
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 20, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820991
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29-JULY-2019: LOT 132515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2013. EXPIRATION DATE: 2018-05-31. 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. OTHER DEVICES INVOLVED IN THE EVENT. GMK-REVISION 02.07.0683R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3, LOT. 182077 (K123721): BATCH REVIEW PERFORMED ON 29-JULY-2019. LOT 182077: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2018. EXPIRATION DATE: 2023-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.09.TA310 TIBIAL AUGMENTATION SIZE 3/10MM, LOT. 185157 (K130299): BATCH REVIEW PERFORMED ON 29-JULY-2019- LOT 185157: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEPT-2018. EXPIRATION DATE: 2023-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0003 OFFSET CONNECTOR 3 MM, LOT. 187637 (K102437): BATCH REVIEW PERFORMED ON 29-JULY-2019- LOT 187637: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2018. EXPIRATION DATE: 2023-10-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FCL10105 EXTENSION STEM - FLUTED Ø 10 L 105 LOT. 115687 (K120790): BATCH REVIEW PERFORMED ON 29-JULY-2019- LOT 115687: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-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 OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0317PSF TIBIAL INSERT PS FIXED SIZE 3/17MM, LOT. 182967 (K090988): BATCH REVIEW PERFORMED ON 29-JULY-2019- LOT 182967: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2018. EXPIRATION DATE: 2023-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS 4 MONTHS AFTER PRIMARY AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706243 GMK-REVISION FEMUR CEMENTED PS SIZE 4NARROW / RIGHT FEMUR CEMENTED JWH MEDACTA INTERNATIONAL SA 132515 07630030820991

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention