BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 7702520 · Received July 19, 2018

    Report

    Report Number
    3005180920-2018-00518
    Event Type
    Injury
    Date Received
    July 19, 2018
    Date of Event
    June 19, 2018
    Report Date
    October 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JULY 2018. LOT 136421: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 FEBRUARY 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: REFERENCE 02.12.0410FR (K121416) TIBIAL INSERT FIXED SPHERE FLEX #4/10 MM R. LOT 140355: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MARCH 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 18 JULY 2018: 4 YEARS AFTER PRIMARY CEMENTED TKA THE SURGEON DECIDED TO RESURFACE THE PATELLA, UPON RECEIVING COMPLAINTS FROM THE PATIENT. DURING SURGERY, THE FEMORAL COMPONENT FIXATION WAS ASSESSED TO BE INSUFFICIENT AND THEREFORE IT WAS EXCHANGED TO A NEW ONE. THE CAUSES FOR REOPERATION DO NOT APPEAR TO BE RELATED TO A MALFUNCTIONING DEVICE.

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER ON SEPTEMBER 17, 2018: FROM THE PICTURE ENCLOSED IT CAN BE SEEN THAT, AFTER THE EXPLANTATION, NO RESIDUAL CEMENT IS PRESENT ON THE INTERNAL POCKETS OF THE FEMORAL COMPONENT. THE FINISHING OF THE BOTTOM SURFACE OF THE FEMORAL COMPONENT SEEMS TO BE IN COMPLIANCE WITH THE SPECIFICATIONS REQUIRED, BUT IT IS VERY DIFFICULT TO CAREFULLY EVALUATE IT BY A PICTURE. 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 IDENTIFIED. FROM THE DESCRIPTION OF THE EVENT AND FROM THE PICTURE ENCLOSED WE CAN'T IDENTIFY ANY POSSIBLE ROOT CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH PATELLA FEMORAL PAIN 4 YEARS AFTER PRIMARY [NO PATELLA RESURFACING COMPLETED IN PRIMARY CASE]. SURGEON PLANNED TO RESURFACE THE PATELLA AND REVISE THE LINER, BUT DURING SURGERY THE FEMORAL COMPONENT WAS FOUND LOOSE (IT CAME OFF VERY EASILY), SO IT WAS REPLACED WITH A NEW ONE, SAME SIZE 4 SPHERE. IN ADDITION, A NEW 12MM POLY AND A INSET PATELLA SIZE 24 WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545701 FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 136421 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention