BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 7854958 · Received September 7, 2018

    Report

    Report Number
    3005180920-2018-00666
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    August 8, 2018
    Report Date
    September 7, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 SEPTEMBER 2018; LOT 171831: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 JULY 2017. EXPIRATION DATE: 2022-07-19; 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 TIBIAL TRAY FIXED CEMENTED SIZE 3 R REFERENCE 02.07.1203R (K090988); LOT 171151: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2017. EXPIRATION DATE: .2022-06-20; 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 INSERT FIXED SPHERE FLEX SIZE 3/13 MM R REFERENCE 02.12.0313FR (K140826); LOT 141417: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 MAY 2014. EXPIRATION DATE: 2019-03-31; 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

    ABOUT 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR KNEE INSTABILITY PROBABLY DUE TO A PREVIOUS PATELLAR TENDON INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695801 FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 171831 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention