BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 RIGHT

    MDR report key: 6944539 · Received October 12, 2017

    Report

    Report Number
    3005180920-2017-00575
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 12, 2017
    Report Date
    March 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED INSERT IS TIBIAL INSERT FIXED SPHERE FLEX # 2/17 MM R REFERENCE. THE POSSIBLE LOT. IS 140348 OR 120349. BATCH REVIEW PERFORMED ON 21 FEB 2018: LOT 140348, (B)(4) PIECES MANUFACTURER AND RELEASED ON 13 MARCH 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALY FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) PIECES OF THE SAME LOT HAS BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LOT 120349: (B)(4) PIECES MANUFACTURER AND RELEASED ON 02 MAY 2012. EXPIRATION DATE: 2017-03-31. NO ANOMALY FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) PIECES OF THE SAME LOT HAS BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. SHE HAD A PRIMARY SURGERY ON (B)(6) 2015. THE PATIENT FELL AND CAME IN COMPLAINING OF PAIN. THE SURGEON NOTICED THE PATELLA WAS LOOSE. ON (B)(6) 2017 THE SURGEON SWAPPED THE POLY AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. THEN THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE TIBIA COMPONENT HAD SUBLUXED AND CAUSED A STRESS FRACTURE ON THE WALL OF HER TIBIA. BATCH REVIEW PERFORMED ON 12 OCTOBER 2017. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE TIBIA COMPONENT HAD SUBLUXED AND CAUSED A STRESS FRACTURE ON THE WALL OF HER TIBIA. THE SURGEON REVISED THE TIBIAL TRAY AND THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724922 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 RIGHT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 152800 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention