BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2018-00587

    MDR report key: 7734714 · Received July 31, 2018

    Report

    Report Number
    3005180920-2018-00587
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    July 10, 2018
    Report Date
    July 31, 2018
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON 26 JULY 2018 THE MEDICAL AFFAIRS MANAGER MADE THE FOLLOWING ANALYSIS: EARLY INFECTION IN CEMENTED TKA, 6 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEWS PERFORMED ON 27 JULY 2018: LOT 172729: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-31. 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. OTHER ITEMS INVOLVED: GMK SPHERE TIBIAL INSERT FIXED FLEX #4/12 MM L REF 02.12.0412FL LOT. 175243 (K121416): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 NOVEMBER 2017. EXPIRATION DATE: 2022-11-15. 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 TIBIAL TRAY FIXED CEMENTED # 4 L REF. 02.07.1204L LOT. 174576 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 SEPTEMBER 2017. EXPIRATION DATE: 2022-09-18. 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 PRIMARY EXTENSION STEM Ø11 MM / L 30 MM REF. 02.07.F11030 LOT. 175972 (K133630): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 DECEMBER 2017. EXPIRATION DATE: 2022-11-07. 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 PATELLA RESURFACING # 1 REF. 02.07.0033RP LOT. 167471 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 FEBRUARY 2017. EXPIRATION DATE: 2022-01-24. 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. GMK TIBIAL WEDGE # 3/5 MM REF. 02.07.03TW LOT. 173946 (K102437): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JUNE 2017. EXPIRATION DATE: 2022-05-29. 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

    REVISION SURGERY DUE TO INFECTION 6 MONTHS AFTER THE PRIMARY.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention