BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 7292102 · Received February 23, 2018

    Report

    Report Number
    3005180920-2018-00096
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    January 25, 2018
    Report Date
    February 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 FEBRUARY 2018: LOT 155738: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 NOVEMBER 2015. EXPIRATION DATE: 2020-10-27. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R REFERENCE 02.07.1204R (K090988): LOT 154010: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 NOVEMBER 2015. EXPIRATION DATE: 2020-10-24. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. TIBIAL INSERT FIXED SPHERE FLEX SIZE4/10 MM R REFERENCE 02.12.0410FR (K121416): LOT 152451: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 NOVEMBER 2015. EXPIRATION DATE: 2020-10-13. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE PATELLA RESURFACING SIZE 2 L REFERENCE 02.07.0034RP (K090988) LOT 160952: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MAY 2016. EXPIRATION DATE: 2021-04-21. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 COMPLAINING OF PAIN 1 YEAR AND 6 MONTHS AFTER PRIMARY: ARTHROFIBROSIS DETECTED. THE SURGEON REVISED ALL MEDACTA HARDWARE AND IMPLANTED A HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136074 FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 155738 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention