BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEXSIZE 5/12 MM R

    MDR report key: 7662371 · Received July 4, 2018

    Report

    Report Number
    3005180920-2018-00477
    Event Type
    Injury
    Date Received
    July 4, 2018
    Date of Event
    June 4, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826788
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SPACER REMOVED ON (B)(6) 2018. PERMANENT HARDWARE WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 JULY 2018; LOT 167325: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 FEBRUARY 2017 EXPIRATION DATE: 18.01.2022; 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. OTHER DEVICES INVOLVED: FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R REFERENCE 02.12.0026R (K140826); LOT 171838: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 AUGUST 2017. EXPIRATION DATE: 29.06.2022. 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. TIBIAL TRAY FIXED CEMENTED SIZE 5 R REFERENCE 02.07.1205R (K090988); LOT 170448:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 JUNE 2017. EXPIRATION DATE:23.05.2022 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. PATELLA RESURFACING SIZE 4 REFERENCE 02.07.0036RP ( 02.07.0036RP); LOT 166115: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2016. EXPIRATION DATE: 2021-11-13; 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 HAD A PRIMARY KNEE ON (B)(6) 2017. ON(B)(6) 2018 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION (RIGHT KNEE). THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. MDR 2018-00013 WAS FILED. ON (B)(6) 2018 (6 MONTHS AFTER THE PREVIOUS SURGERY) THE PATIENT WAS REVISED DUE TO SIGN OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504679 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEXSIZE 5/12 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 167325 07630030826788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention