BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 RIGHT

    MDR report key: 5932026 · Received September 7, 2016

    Report

    Report Number
    3005180920-2016-00454
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    August 8, 2016
    Report Date
    September 7, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 19 AUGUST 2016 AND INCLUDES: AN INFECTION WAS CONFIRMED, BUT THE PATHOGEN RESULT WILL NOT BECOME AVAILABLE. BATCH REVIEWS PERFORMED ON 02 SEPTEMBER 2016. LOT 154708: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 OCTOBER 2015. EXPIRATION DATE: 2020-10-05. 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-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 RIGHT, CODE 02.12.T3I4R, LOT. 154155 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 NOVEMBER 2015. EXPIRATION DATE: 2020-10-24. 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. 151408 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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 4/11 MM RIGHT, CODE 02.12.0411FR, LOT. 152452 (K140826) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JULY 2015. EXPIRATION DATE: 2020-06-30. 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 06 SEPTEMBER 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS INITIAL REPORT. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION MAY HAVE CAUSED THE IMPLANTS TO BECOME LOOSE. THE SURGEON REVISED THE FEMORAL COMPONENT, THE RESURFACING PATELLA, TIBIAL TRAY AND THE TIBIAL INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584891 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 RIGHT CEMENTED KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 154708

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention