BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 7893367 · Received September 20, 2018

    Report

    Report Number
    3005180920-2018-00704
    Event Type
    Injury
    Date Received
    September 20, 2018
    Date of Event
    August 22, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE EXPLANTED TIBIA TRAY AND INLAY PERFORMED BY R&D PRODUCT MANAGER ON 30 OCTOBER 2018. REVISION SURGERY AFTER 1 YEAR AND 9 MONTHS FROM PRIMARY SURGERY DUE TO TIBIA POSTERO-LATERAL LOOSENING AND SUBSIDENCE. TIBIAL INSERT LOOKS MORE WORN ON THE POSTERIOR PART ON THE LATERAL SIDE. IT IS IMPOSSIBLE TO KNOW IF THIS IS THE EFFECT OF THE POSTERO LATERAL SUBSIDENCE OR AN EVIDENCE OF AN IMPLANT MALPOSITIONING DURING PRIMARY SURGERY. NO FURTHER CONSIDERATIONS RELATED TO THE EVENT CAN BE DONE FROM VISUAL INSPECTION OF THE COMPONENTS.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2018. LOT 163310: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 SEPTEMBER 2016. EXPIRATION DATE: 2021-07-27 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON 20 SEPTEMBER 2018. REVISION OF CEMENTED TIBIAL COMPONENT OCCURRED 1 YEAR AND 9 MONTHS AFTER PRIMARY TKR IN A HEAVY ((B)(6)) ELDERLY ((B)(6)) PATIENT. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF SUBSIDED TIBIAL COMPONENT. INITIAL IMPLANT POSITION CANNOT BE ASSESSED NOT HAVING AN IMMEDIATE POST PRIMARY X-RAY. ACCORDING TO THE REPORT, A TRAUMATIC EVENT CAN BE THE CAUSE OF THIS FAILURE.

    Description of Event or Problem · 1

    REVISION TIBIAL PLATEAU FOR POSTERO LATERAL SUBSIDENCE AND LOOSENING 1 YEAR AND 10 MONTHS AFTER THE PRIMARY. NOTE: THERE IS A SUSPICION OF FALL DOWN OF THE PATIENT, NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734920 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 163310 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention