BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 LEFT

    MDR report key: 6662720 · Received June 23, 2017

    Report

    Report Number
    3005180920-2017-00328
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    May 24, 2017
    Report Date
    June 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 13 JUNE 2017 AND INCLUDES: DURING REVISION SURGERY, THE SURGEON TOOK FEMORAL COMPONENT EASILY, AND ON THE FEMORAL COMPONENT INNER SURFACE, THERE WAS NO CEMENT. THE FEMORAL COMPONENT WAS DEBONED. ON 13 JUNE 2017, THE (B)(4) PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE INFORMATION RECEIVED ON THE SAME DAY, AND COMMENTED AS FOLLOWS: IF WE LOOK AT REVISION CASES, EXCLUDING CASES WHICH LOOSENING IS THE MAIN CAUSE FOR REVISION, IT IS SOMETHING USUAL TO FIND THE EXPLANTED FEMORAL OR TIBIA COMPONENT WITHOUT ANY TRACES OF CEMENT OR MAYBE FEW TRACES IN THE CEMENTATION POCKET SINCE CEMENT IS A FILLER AND NOT AN ADHESIVE. USUALLY THE CEMENT IS FOUND COMPLETELY ADHERING THE BONE AFTER ABLATION OF THE IMPLANT. WHAT IS NOT USUAL, IS THE POSSIBILITY TO EXPLANT THE COMPONENT TOO EASILY. CEMENT, PRESS-FIT ON THE INTERNAL SHAPE OF THE COMPONENT AND PRESS-FIT OF THE PEGS HAVE TO GUARANTEE THE APPROPRIATE STABILITY AND FIXATION TO AVOID LOOSENING. NO FURTHER CONSIDERATIONS CAN BE DONE WITH THE INFORMATION PROVIDED. BATCH REVIEWS PERFORMED ON 20 JUNE 2017. LOT 160115: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MARCH 2016. EXPIRATION DATE: 2021-03-09. 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-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT, CODE 02.07.1204L, LOT. 162457 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-06-26. 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-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM LEFT, CODE 02.12.0410FL, LOT. 161951 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JUNE 2016. EXPIRATION DATE: 2021-05-31. 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.

    Description of Event or Problem · 1

    DUE TO INFECTION, THE SURGEON PLANNED TO REMOVE THE IMPLANTS AND CEMENT MANTLE. ALL IMPLANTS WERE EXTRACTED AND CEMENT SPACER WAS INSERTED. ADDITIONAL SURGERY IS NECESSARY, BUT IT WAS NOT SCHEDULED YET. DEPENDING ON THE PATIENT CONDITION, THE SURGEON WILL PLAN AND PERFORM ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445557 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 LEFT KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 160115

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention