BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/17 MM R

    MDR report key: 11331084 · Received February 16, 2021

    Report

    Report Number
    3005180920-2021-00125
    Event Type
    Injury
    Date Received
    February 16, 2021
    Date of Event
    January 19, 2021
    Report Date
    February 16, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826269
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15.FEB.2021: LOT 154771: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JAN-2016. EXPIRATION DATE: 2021-01-06. 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 DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 15.FEB.2021: GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT 182896: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2018. EXPIRATION DATE: 2023-09-04. 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. GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R (K140826) LOT 181857: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2018. EXPIRATION DATE: 2023-05-31. 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

    THE PATIENT CAME IN 2 MONTHS AFTER PREVIOUS REVISION SURGERY (PRIMARY IN 2018) DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL THE IMPLANTS EXCEPT THE PATELLA AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS THE 3RD REVISION SURGERY FOR THIS PATIENT. THE PREVIOUS REVISIONS WERE PERFORMED DUE TO QUAD TENDON REPAIR (INSET REVISED) AND INFECTION (WASHOUT AND INSERT REVISION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232033 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/17 MM R KNEE TIBIAL LINER JWH MEDACTA INTERNATIONAL SA 02.12.0217FR 154771 07630030826269

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention