BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 2 R

    MDR report key: 8744216 · Received June 28, 2019

    Report

    Report Number
    3005180920-2019-00522
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825422
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 JUN 2019. LOT 162147: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAY-2016. EXPIRATION DATE: 20-04-2021. 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. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2019. GMK-HINGE 02.07.216FDA FEMORAL AUGMENTATION DISTAL SIZE 2/16MM (K163311) LOT. 161349 LOT 161349: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2016. EXPIRATION DATE: 21-04-2020. 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. TWO ITEMS WITH THE SAME LOT ARE REPORTED IN THIS EVENT. GMK-HINGE 02.07.FCL15150 EXTENSION STEM - FLUTED Ø 15 L 150 (K120790), LOT. 162546. LOT 162546: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2016. EXPIRATION DATE: 27-07-2021. 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-HINGE 02.09.4001R FIXED TIBIAL TRAY SIZE 1 R (K130299), LOT. 164808. LOT 164808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2016. EXPIRATION DATE: 28-08-2021. 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-HINGE 02.09.0120H FIXED TIBIAL INSERT SIZE 1/20MM (K130299), LOT. 161838. LOT 161838: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2016. EXPIRATION DATE: 28-03-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD. GMK-HINGE 02.09.TA110 TIBIAL AUGMENTATION SIZE 1/10MM (K130299), LOT. 123243. LOT 123243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2013. EXPIRATION DATE: 31-12-2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. GMK-HINGE 02.09.TA110 TIBIAL AUGMENTATION SIZE 1/10MM (K130299), LOT. 148083. LOT 148083: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUL-2015. EXPIRATION DATE: 31-03-2020. 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-HINGE 02.07.FCL13105 EXTENSION STEM - FLUTED Ø 13 L 105 (K120790), LOT. 162539. LOT 162539: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 04-07-2021. 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

    THE PATIENT CAME IN, TWO YEARS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537537 GMK-HINGE FEMORAL COMPONENT SIZE 2 R KNEE FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 162147 07630030825422

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention