BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 2 RIGHT

    MDR report key: 5917447 · Received August 31, 2016

    Report

    Report Number
    3005180920-2016-00442
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 31, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE PATIENT MATCHED DEPARTMENT PERFORMED A PATIENT MATCHING REVIEW: THE ANALYSIS OF THE PROCESS OF THIS CASE FOUND NO DEVIATION FROM THE STANDARD PROCEDURE. BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 092093: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 NOVEMBER 2009. EXPIRATION DATE: 2014-09-30. 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. GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 RIGHT, CODE (B)(4), LOT. 100135 ((B)(4)), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 FEBRUARY 2010. EXPIRATION DATE: 2015-01-31. 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 PS FIXED SIZE 2/12MM, CODE (B)(4), LOT. 080157 ((B)(4)), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2008. EXPIRATION DATE: 2013-01-31. 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 PATELLA RESURFACING SIZE 1, CODE (B)(4), LOT. 092347 ((B)(4)), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 OCTOBER 2009. EXPIRATION DATE: 2014-08-31. 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. ON 31 AUGUST 2016 THE R&D PROJECT MANAGER MADE THE FOLLOWING ANALYSIS BASED ON THE IMAGE OF THE EXPLANTS: PRELIMINARY INSPECTION OF THE EXPLANTED TIBIA COMPONENT: FROM THE PICTURE ENCLOSED IT CAN BE SEEN THAT, AFTER THE EXPLANTATION, NO RESIDUAL CEMENT IS PRESENT ON THE BOTTOM SURFACE OF THE TIBIA TRAY. THE FINISHING OF THE BOTTOM SURFACE OF THE TIBIA TRAY SEEMS TO BE IN COMPLIANCE WITH THE SPECIFICATIONS REQUIRED. POCKETS TO HOST THE CEMENT ARE PRESENT. NO ELEMENTS THAT CAN LET US SUPPOSE A BAD ADHESION OF THE CEMENT TO THE COMPONENT CAN BE IDENTIFY. PRELIMINARY INSPECTION OF THE EXPLANTED FEMORAL COMPONENT: FROM THE PICTURE ENCLOSED IT CAN BE SEEN THAT THE MOST PART OF THE CEMENT WAS ADHERING TO THE FEMORAL COMPONENT AFTER THE EXPLANTATION. PRELIMINARY INSPECTION OF THE EXPLANTED TIBIA INSERT: THE EXPLANTED TIBIA INSERT DOESN'T PRESENT ANY ANOMALIES. THE ARTICULAR SURFACE SEEMS TO BE REGULARLY WORN AS EXPECTED AFTER SIX YEARS FROM IMPLANTATION. CONCLUSION: FROM THE DESCRIPTION OF THE EVENT AND FROM THE PICTURE ENCLOSED IT CAN'T BE IDENTIFY ANY POSSIBLE ROOT CAUSE FOR THE EVENT. : NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON NOTICED THAT THE BONE CEMENT DID NOT ADHERE TO THE TIBIAL TRAY AND DID NOT ADHERE TO THE BONE ON THE FEMORAL SIDE. THE SURGEON REVISED ALL THE PRIMARY COMPONENTS INCLUDING THE FEMUR, TIBIAL TRAY, TIBIAL INSERT AND PATELLA RESURFACING. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568546 GMK-PRIMARY FEMUR PS CEMENTED SIZE 2 RIGHT KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 092093

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention