BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+

    MDR report key: 6391146 · Received March 9, 2017

    Report

    Report Number
    3005180920-2017-00103
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    February 1, 2017
    Report Date
    March 9, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS NOT THE FIRST REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT HAD SUSPICION OF INFECTION AND HAD A LINER CHANGED IN (B)(6) 2016. THEN, THE PATIENT CAME IN AGAIN COMPLAINING OF PERSISTANT PAIN. ADDITIONAL INFORMATION RECEIVED ON 16 FEBRUARY 2017 AND INCLUDES: THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017. THE FIRST REVISION SURGERY DATE WAS ON (B)(6) 2016. BATCH REVIEWS PERFORMED ON 07 MARCH 2017. LOT 152892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-31. 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. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT, CODE 02.07.1203L, LOT. 152349 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JUNE 2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM LEFT, CODE 02.12.0310FL, LOT. 153532 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 OCTOBER 2015. EXPIRATION DATE: 2020-10-04. 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 PATELLA RESURFACING SIZE 2, CODE 02.07.0034RP, LOT. 154687 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2015. EXPIRATION DATE: 2020-10-07. 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 08 MARCH 2017 THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: SECONDARY INFECTION IN A CEMENTED TOTAL TKA AFTER ONE YEAR. INFECTION WAS CONFIRMED, ACCORDING TO THE REPORT. LATE INFECTION ARE A KNOWN, POSSIBLE ADVERSE EVENT FOLLOWING TJA. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE AT THIS STAGE.

    Description of Event or Problem · 1

    THE PATIENT HAD PERSISTANT PAIN AND THE SURGEON INVESTIGATED INFECTION TO FIND PROPRIONIBACTERIUM IS THE ORGANISM. THE SURGEON DECIDED TO DO A 2-STAGE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173335 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 152892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention