BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM

    MDR report key: 9882641 · Received March 26, 2020

    Report

    Report Number
    3005180920-2020-00192
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    February 27, 2020
    Report Date
    March 26, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817847
    PMA / PMN Number
    K090988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 MARCH 2020: LOT 1900591: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-05-08. 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 ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 10 MARCH 2020: GMK-REVISION 02.07.10.4563 TORQUE LIMITER WRENCH - 6NM LOT 1752438: LOT 1752438: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE NO ANY SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    DURING FINAL IMPLANTATION OF A REVISION KNEE SURGERY, THE TIBIAL INSERT SCREW HAD BROKEN OF WHILE THE SURGEON WAS ATTEMPTING TO PUT THE POLY ON WITH THE TORQUE LIMITING DRIVER. AS A RESULT, THE THREADED PORTION OF THE INSERT SCREW WAS STUCK AND COULD NOT BE REMOVED FROM THE BASEPLATE. THE SURGEON HAD TO REMOVE THE POLY AND THE AGENT HAD TO PROVIDE ANOTHER POLY (UC POLY) TO COMPLETE THE CASE. THERE WAS A 10 MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SCREWDRIVER USED IS NOT CORRECT BECAUSE HAS A TOURQUELIMITER OF 6 NM INSTEAD OF THE CORRECT ONE THAT HAS A TOURQUELIMITER OF 3.5 NM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345564 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0414PSF 1900591 07630030817847

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other