BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 7306121 · Received March 1, 2018

    Report

    Report Number
    3005180920-2018-00105
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    January 30, 2018
    Report Date
    March 1, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PERFORMED ON 23 FEBRUARY 2018 BY PATIENT MATCH DEPARTMENT: OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2018 LOT 153545: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 AUGUST 2015. EXPIRATION DATE: 2020-06-30 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R REFERENCE 02.07.1204R (K090988) LOT 152355: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2015. EXPIRATION DATE: 2020-05-31 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. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER: REVISION SURGERY AFTER 2 YEARS FROM PRIMARY TKA FOR INSTABILITY. FROM THE PICTURE OF THE EXPLANTED FEMORAL COMPONENT, NO RESIDUAL CEMENT CAN BE SEEN ON THE INTERNAL SURFACE OF THE IMPLANT IN CONTACT WITH THE BONE. IT IS SOMETHING USUAL TO BE SEEN ON EXPLANTED COMPONENTS, EVEN IF THE CAUSE OF REVISION IS NOT INSTABILITY, LOOSENING OR MOBILIZATION. SO, A CEMENTATION PROBLEM COULD BE THE CAUSE OF THE EVENT BUT THE ABSENCE OF CEMENT ON THE INTERNAL SURFACE IS NOT AN EVIDENCE OF A LACK OF INTEGRATION BETWEEN THE CEMENT AND THE BONE. CEMENTATION PROBLEMS ARE MOST LIKELY LINKED TO SEVERAL FACTORS NOT IMPLANT RELATED. NO FURTHER CONSIDERATIONS CAN BE DONE LOOKING AT THE PICTURE ENCLOSED.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2016. IN (B)(6) 2017 THE PATIENT CAME IN DUE TO FEELING UNSTABLE. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON SWAPPED THE INSERT ON (B)(6) 2017 [MDR (B)(4)] . THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THAT THE CEMENT DID NOT ADHERE TO THE IMPLANTS CAUSING THE INSTABILITY. THE SURGEON REVISED ON (B)(6) 2018 THE FEMUR, INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151334 FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 153545 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention