BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / RIGHT

    MDR report key: 6965216 · Received October 20, 2017

    Report

    Report Number
    3005180920-2017-00597
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 20, 2017
    Report Date
    October 20, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820991
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 13 OCTOBER 2017 THE PATIENT MATCH DEPARTMENT PROVIDED A PROCESS REVIEW REPORTING AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. ON 19 OCTOBER 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: PARTIAL REVISION OF PRIMARY CEMENTED TKA AFTER 3 YEARS. A FIXED, ULTRA-CONGRUENT TIBIAL BASEPLATE WAS REPLACED WITH A THICKER INSERT AND A STEMMED IMPLANT. THE PRIMARY IMPLANTATION APPEARS TO HAVE VERY PRONOUNCED POSTERIOR SLOPE OF THE TIBIAL COMPONENT AND A LATERAL SHIFT; THESE CONDITIONS MAY RESULT IN (POSTERIOR, PROBABLY) INSTABILITY OF THE JOINT, DEPENDING ON LIGAMENT CONDITIONS AND PATIENT ACTIVITY AND FITNESS. WE HAVE NO INFORMATION AS TO THE CONDITIONS THAT LED TO THIS PARTICULAR PLACEMENT. THERE IS NO REASON TO SUSPECT A FAULTY IMPLANT AT THE ORIGIN OF THE PROBLEM. BATCH REVIEWS PERFORMED ON 17 OCTOBER 2017. LOT 156165: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JANUARY 2016. EXPIRATION DATE: 2021-01-16. 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 3/10MM, CODE 02.07.0310PSF, LOT. 160590 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MAY 2016. EXPIRATION DATE: 2021-05-05. 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 3 RIGHT, LOT. 164077 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 SEPTEMBER 2016. EXPIRATION DATE: 2021-09-06. 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 20 OCTOBER 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE EXPLANTED COMPONENTS AND COMMENTED AS FOLLOWS: - FEMORAL COMPONENT: SOME RESIDUAL CEMENT CAN BE NOTED ON THE INTERNAL SURFACE OF THE FEMORAL COMPONENT, MAINLY IN THE DISTAL PART. SEVERAL DENTS AND SCRATCHES CAN BE NOTED ON THE ARTICULAR SURFACE OF THE COMPONENT. THEY WERE MAINLY CAUSED DURING THE ATTEMPT TO EXPLANT THE COMPONENT. IN FACT, THEY CAN'T BE SEEN IN THE PICTURE OF THE COMPONENT NOT EXPLANTED YET. - TIBIA COMPONENT: NO RESIDUAL CEMENT CAN BE SEEN ON THE DISTAL SURFACE OF THE EXPLANTED COMPONENT. IT IS SOMETHING USUAL TO BE SEEN ON EXPLANTED COMPONENT, SINCE THE CEMENT IS A FILLER AND NOT AN ADHESIVE. DEGREE OF FINISHING OF THE DISTAL SURFACE OF THE COMPONENT SEEMS TO BE IN COMPLIANCE WITH THE SPECIFICATION REQUIRED. - TIBIA INSERT: NO RELEVANT CONSIDERATIONS RELATED TO THE EVENT CAN BE DONE FROM VISUAL INSPECTION OF THE EXPLANTED COMPONENT. CONCLUSION: FROM VISUAL INSPECTION THERE IS NO EVIDENCE THAT MAY LEAD US RELATE THE EVENT TO A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF STIFFNESS. THE SURGEON DETERMINED THE CEMENT (NON-MEDACTA PRODUCT) DID NOT ADHERE TO THE IMPLANTS. THE SURGEON REVISED THE FEMUR, INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744611 GMK-PRIMARY FEMUR CEMENTED PS SIZE 4NARROW / RIGHT KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 156165 07630030820991

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention