BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

    MDR report key: 9591143 · Received January 15, 2020

    Report

    Report Number
    3005180920-2019-01139
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    December 16, 2019
    Report Date
    March 24, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815737
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO PAIN IN THE PATELLA AND SHOWING SIGNS OF AN INFECTION. THE SURGEON REVISED THE FEMORAL COMPONENT, POLY, RESURFACED THE PATELLA AND ADDED AN EXTENSION STEM 2 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 168749: 50 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: 2022-04-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 47 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2020: GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L (K121416) LOT 172775: 60 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: 2022-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 59 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO PAIN IN THE PATELLA AND SHOWING SIGNS OF AN INFECTION. THE SURGEON REVISED THE FEMORAL COMPONENT, POLY, RESURFACED THE PATELLA AND ADDED AN EXTENSION STEM 2 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 DECEMBER 2019. LOT 171205: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUN-2017. EXPIRATION DATE: 2022-05-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 COMPLAINING OF ANTERIOR KNEE PAIN 2 YEARS AND 3 MONTHS AFTER PRIMARY. THE SURGEON PLANS TO RESURFACE THE PATELLA AND A REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2020 . MORE DETAILS TO FOLLOW ONCE THE CASE HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54729 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L KNEE CEMENTED FEMORAL IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0033RP 168749 07630030815737

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention