BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    MDR report key: 12165677 · Received July 14, 2021

    Report

    Report Number
    3005180920-2021-00581
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23.JUNE.2021: LOT 168515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-03-2017. EXPIRATION DATE: 2022-03-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENTS SINCE 2017. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0021R FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R (K140826), LOT. 142556 BATCH REVIEW PERFORMED ON 23.JUNE.2021: LOT 142556: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-05-2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    3 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT REPORTED INSTABILITY. A BONE SCAN REVEALED LOOSE IMPLANTS. THE SURGEON DECIDED TO REVISE ALL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062351 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1202R 168515 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention