BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 RIGHT

    MDR report key: 6944526 · Received October 12, 2017

    Report

    Report Number
    3005180920-2017-00572
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 12, 2017
    Report Date
    October 12, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE PATIENT MATCHED DEPARTMENT PROVIDED A PLANNING REVIEW OF THIS CASE, REPORTING AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. BATCH REVIEWS PERFORMED ON 12 OCTOBER 2017. LOT 161661: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 APRIL 2016. EXPIRATION DATE: 2021-03-30. 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 4/14 MM RIGHT, CODE 02.12.0414FR, LOT. 144285 (K121416) LOT 144285: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 SEPTEMBER 2014. EXPIRATION DATE: 2019-08-31. 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 4 RIGHT, CODE 02.07.1204R, LOT. 147379 (K090988) LOT 147379: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 FEBRUARY 2015. EXPIRATION DATE: 2019-12-31. 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 PATELLA RESURFACING SIZE 3, CODE 02.07.0035RP, LOT. 160953 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MAY 2016. EXPIRATION DATE: 2021-04-21. 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

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND RE-IMPLANTED NEW HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724766 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 RIGHT KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 161661 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention