BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE FIXED TIBIAL TRAY CEMENTED SIZE 2 R

    MDR report key: 8260587 · Received January 18, 2019

    Report

    Report Number
    3005180920-2018-01104
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    December 19, 2018
    Report Date
    May 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT FAMILY NAME WAS CORRECTED FROM GMK-PRIMARY TO GMK-SPHERE, THE REFERENCE AND LOT WERE CORRECT; ANYWAY, THE BATCH REVIEW WAS RE-PERFORMED ON MAY 3, 2019 WITH THE UPDATED SALES DATA: LOT 184108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2018. EXPIRATION DATE: 2023-10-18 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. THE ADDITIONAL IMPLANT INVOLVED IN THE ISSUE WAS NOT THE TIBIAL INSERT (AS WRONGLY REPORTED IN THE INITIAL REPORT), BUT THE GMK-SPHERE 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM LOT. 182980. THE BATCH REVIEW WAS PERFORMED ON MAY 3, 2019: LOT 182980: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2108. EXPIRATION DATE: 2023-06-25. 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.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JANUARY 2019.LOT 185610: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 SEPTEMBER 2018 . EXPIRATION DATE: 2023-09-09.NO ANOMALIES FOUND RELATED TO THE PROBLEM.TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY FIXED TIBIAL TRAY CEMENTED SIZE 2 R REFERENCE 02.07.1202R (K090988). LOT 184108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2018. EXPIRATION DATE: 2023-10-18.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

    DURING THE PRIMARY KNEE SURGERY, WHILE ATTEMPTING TO CONNECT THE TIBIAL TRAY TO THE EXTENSION STEM, THE SCREW WOULD NOT ENGAGE WITH THE STEM. THE SURGEON CHOSE TO IMPLANT THE EXTENSION STEM AND TIBIAL TRAY WITHOUT THE SCREW AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54454 GMK-SPHERE FIXED TIBIAL TRAY CEMENTED SIZE 2 R FIXED TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 184108 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 Other