BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT

    MDR report key: 6296392 · Received February 2, 2017

    Report

    Report Number
    3005180920-2017-00008
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    January 3, 2017
    Report Date
    February 2, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE THIRD REVISION SURGERY UNDERGONE BY THE PATIENT. THE PATIENT HAD A PRIMARY KNEE ON (B)(6) 2014. SHE HAD A POLY SWAP ON (B)(6) 2014. ON (B)(6) 2015 THE PATIENT HAD ANOTHER POLY SWAP BECAUSE SHE FELL, CAUSING THE SOFT TISSUE TO STRETCH. THE SURGEON INCREASED HER INSERT FROM A 17MM TO A 20MM TO STABILIZE THE KNEE. ON (B)(6) 2017 THE PATIENT CAME IN FOR A THIRD REVISION. BATCH REVIEWS PERFORMED ON 30 JANUARY 2017. LOT 135457: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 FEBRUARY 2014. EXPIRATION DATE: 2019-01-31. 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-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 20 MM, CODE 02.07.0320FUC, LOT. 131903 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2013. EXPIRATION DATE: 2018-06-30. 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 COMPLAINING OF PAIN. THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON SWAPPED THE TIBIAL TRAY AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81439 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 135457

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention