BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5

    MDR report key: 9394956 · Received December 2, 2019

    Report

    Report Number
    3005180920-2019-01001
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 NOVEMBER 2019. LOT 182891: 89 ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2018. EXPIRATION DATE: 2023-09-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 75 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT. GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 LOT. 184169 (K090988). BATCH REVIEW PERFORMED ON 06 NOVEMBER 2019. LOT 184169: 180 ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2018. EXPIRATION DATE: 2023-07-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 166 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L LOT. 183023 (K121416) BATCH REVIEW PERFORMED ON 06 NOVEMBER 2019. LOT 183023: 100 ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-06-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 84 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0006L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L LOT. 183478 (K121416) BATCH REVIEW PERFORMED ON 06 NOVEMBER 2019: LOT 183478: 57 ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2018. EXPIRATION DATE: 2023-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 38 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS FROM THE PATIENT AND THEN IMPLANTED ALL NEW IMPLANTS ALMOST 1 YEAR AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191172 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 182891 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention