BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 10521605 · Received September 11, 2020

    Report

    Report Number
    3005180920-2020-00605
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    August 14, 2020
    Report Date
    September 11, 2020
    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 26 AUGUST 2020: LOT 187175: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2018. EXPIRATION DATE: 2023-11-20. 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. OTHER DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0314FR TIBIAL INSERT FIXED SPHERE FLEX #3/14 MM R LOT. 186067 (K121416) BATCH REVIEW PERFORMED ON 26 AUGUST 2020: LOT 186067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2018. EXPIRATION DATE: 2023-10-25. 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 02.07.1203R TIBIAL TRAY FIXED CEMENTED # 3 R LOT. 1810468 (K090988). BATCH REVIEW PERFORMED ON 26 AUGUST 2020: LOT 1810468: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-03-12. 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 02.07.0033RP PATELLA RESURFACING # 1 LOT. 1900599 (K090988). BATCH REVIEW PERFORMED ON 26 AUGUST 2020: LOT 1900599: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2019. EXPIRATION DATE: 2024-04-15. 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 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM LOT. 188116 (K133630). BATCH REVIEW PERFORMED ON 26 AUGUST 2020: LOT 188116: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2018. EXPIRATION DATE: 2023-12-10. 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 CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 1 YEAR AFTER PRIMARY SURGERY THE SURGEON REMOVED ALL COMPONENT'S AND IMPLANTED A MEDACTA FEMUR AND INSERT WITH ANTIBIOTIC CEMENT TO ACT AS A TEMPORARY SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986694 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0023R 187175 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention