BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

    MDR report key: 9502122 · Received December 20, 2019

    Report

    Report Number
    3005180920-2019-01095
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 20, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862441
    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 13 DECEMBER 2019: LOT 171838: 26 ITEMS MANUFACTURED AND RELEASED ON 28 AUGUST 2017. EXPIRATION DATE: 2022-06-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. OTHER IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 13 DECEMBER 2019. GMK-SPHERE 02.07.0035RP PATELLA RESURFACING # 3 (K090988) LOT. 173745. LOT 173745: 120 ITEMS MANUFACTURED AND RELEASED ON 19 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 119 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED # 5 R (K090988) LOT. 171961. LOT 171961: 109 ITEMS MANUFACTURED AND RELEASED ON 7 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 109 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0514FR TIBIAL INSERT FIXED SPHERE FLEX # 5/14 MM R (K121416) LOT. 134449 LOT 134449: 25 ITEMS MANUFACTURED AND RELEASED ON 13 NOVEMBER 2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 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 (K133630) LOT. 173740 LOT 173740: 100 ITEMS MANUFACTURED AND RELEASED ON 4 OCTOBER 2017. EXPIRATION DATE: 2022-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 90 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 WAS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300392 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 171838 07630030862441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention