BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM

    MDR report key: 8784034 · Received July 12, 2019

    Report

    Report Number
    3005180920-2019-00607
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825033
    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 02 JUL 2019: LOT 162429: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2016. EXPIRATION DATE: 19-04-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 02 JUL 2019. GMK-HINGE 02.09.4001L FIXED TIBIAL TRAY SIZE 1 L (K130299) LOT. 154266. LOT 154266: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-SEP-2015. EXPIRATION DATE: 31-07-2020. 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 02.09.2602L FEMORAL COMPONENT SIZE 2 L (K130299) LOT. 156526. LOT 156526: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2016. EXPIRATION DATE: 31-01-2021. 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.TA105 TIBIAL AUGMENTATION SIZE 1/5MM (K130299) LOT. 148082. LOT 148082: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-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. IN THIS COMPLAINT TWO DEVICES WERE INVOLVED WITH THE SAME LOT NUMBER. GMK-HINGE 02.07.FCL14105 EXTENSION STEM - FLUTED Ø 14 L 105 (K120790) LOT. 164186. LOT 164186: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2016. EXPIRATION DATE: 30-08-2021. 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 02.07.220FDA FEMORAL AUGMENTATION DISTAL SIZE 2/20MM (K163311 ) LOT. 161346. LOT 161346: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-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. (B)(4) ITEMS ARE PRESENT IN THIS COMPLAINT WITH THE SAME LOT NUMBER. GMK-HINGE 02.07.FCL15150 EXTENSION STEM - FLUTED Ø 15 L 150 (K120790) LOT. 155895. LOT 155895: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-FEB-2016. EXPIRATION DATE: 20-01-2021. 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 PERFORMED A WASHOUT AND REVISED THE POLY, TIBIAL TRAY, FEMORAL COMPONENT, AUGMENTS AND EXTENSION STEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577444 GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM KNEE FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 162429 07630030825033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention