BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4

    MDR report key: 8178703 · Received December 19, 2018

    Report

    Report Number
    3005180920-2018-01014
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    November 21, 2018
    Report Date
    December 19, 2018
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 DECEMBER 2018: LOT 167359: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MARCH2017. EXPIRATION DATE: 2022-02-27. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM R REFERENCE 02.12.0417FR (K121416). LOT 168359: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 FEBRUARY 2017. EXPIRATION DATE: 2022-02-08. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 R REFERENCE 02.12.T3I4R. LOT 168376: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MARCH 2017. EXPIRATION DATE: 2022-07-03. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE PATELLA RESURFACING SIZE 2 REFERENCE 02.07.0034RP (K090988). BATCH REVIEW PERFORMED ON 18 DECEMBER 2018: LOT 170489: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MAY 2017. EXPIRATION DATE: 2022-04-24. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 HAD A PRIMARY TOTAL KNEE SURGERY ON (B)(6) 2017. THE PATIENT NOW REPORTS THAT SHE IS EXPERIENCING PAIN AND DISCOMFORT THAT CAUSES HER TO BE UNABLE TO WALK, 4 MONTHS AFTER PRIMARY. NO ADDITIONAL DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019447 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 167359 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention