BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 9375451 · Received November 26, 2019

    Report

    Report Number
    3005180920-2019-01000
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 26, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11-NOVEMBER-2019. LOT 186211: 71 ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2018. EXPIRATION DATE: 11/11/2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 61 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOVED: GMK-SPHERE 02.12.0004R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R (K121416) LOT. 178715. BATCH REVIEW PERFORMED ON 11-NOVEMBER-2019. LOT 178715: 62 ITEMS MANUFACTURED AND RELEASED ON14-MAR-2018. EXPIRATION DATE: 05.03.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 58 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOVED: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX #4/10 MM R (K121416) LOT. 187257. BATCH REVIEW PERFORMED ON 11-NOVEMBER-2019. LOT 187257: 75 ITEMS MANUFACTURED AND RELEASED ON 08-JAN-2019. EXPIRATION DATE: 11/12/2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 69 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO KNEE PAIN 7 MONTHS AFTER PRIMARY. THE SURGEON RESURFACED THE PATELLA AND REVISED THE INLAY (SAME SIZE, SAME HEIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172679 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 186211 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention