BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 7812472 · Received August 24, 2018

    Report

    Report Number
    3005180920-2018-00630
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    July 24, 2018
    Report Date
    August 24, 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 23 AUGUST 2018. LOT 160142: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 MARCH 2016. EXPIRATION DATE: 2021-03-06 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. OTHER DEVICE INVOLVED: TIBIAL INSERT FIXED SPHERE FLEX #2/14 MM R REFERENCE 02.12.0214FR (K121416) LOT 154770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 JANUARY 2016. EXPIRATION DATE: 2021-01-05 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. PATIENT MATCH INVESTIGATION DONE ON 22 AUGUST 2018. OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AND 9 MONTHS AFTER PRIMARY: THE MCL HAD RUPTURED. POST MCL REPAIR THE SURGEON NOTICED THAT THE PATIENT PRESENTED WITH A VALGUS ALIGNMENT: HE RECUT THE FEMUR TO FIT A SIZE 3 GMK REVISION PS FEMUR AND REVISED ALSO INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656278 FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 160142 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 113 YR Required Intervention