BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

    MDR report key: 8844856 · Received July 31, 2019

    Report

    Report Number
    3005180920-2019-00659
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    July 12, 2019
    Report Date
    July 31, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816833
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JULY 2019: LOT 146760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-OCT-2017. EXPIRATION DATE: 2019-09-30. 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 EVENTS. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN HINGED TOTAL KNEE ARTHROPLASTY, 2 YEARS AFTER IMPLANTATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. OTHER IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 18 JULY 2019. GMK-REVISION 02.07.0682R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R (K123721) LOT. 164179 LOT 164179: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2016. EXPIRATION DATE: 2021-09-20. 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 (K102437) LOT. 165116. LOT 165116: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2016. EXPIRATION DATE: 2021-10-30. 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.FSC13065 EXTENSION STEM - CEMENTED Ø 13 L 65 (K120790) LOT. 168992 LOT 168992: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2017. EXPIRATION DATE: 2022-04-22. 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.TA210 TIBIAL AUGMENTATION SIZE 2/10MM (K130299) LOT. 142998 LOT 142998: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUN-2014. EXPIRATION DATE: 2019-04-30. 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. GMK-REVISION 02.09.TA210 TIBIAL AUGMENTATION SZE 2/10MM (K1302999 LOT. 146735 LOT 146735: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2014. EXPIRATION DATE: 2019-09-30. 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 HAD TIBIAL LOOSENING THAT WAS CAUSED BY AN INFECTION. THE SURGEON PERFORMED A REVISION OF THE IMPLANT 1 YEAR AND 10 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642860 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 146760 07630030816833

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention