BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2018-00556

    MDR report key: 7731855 · Received July 30, 2018

    Report

    Report Number
    3005180920-2018-00556
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 30, 2018
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION RECEIVED: ON (B)(6) 2017, PRIMARY; ON (B)(6) 2018, SPACER IMPLANTED (MDR 2018-00113); ON (B)(6) 2018 NEW IMPLANTS; ON (B)(6) 2018 SECOND REVISION FOR INFECTION, SPACER IMPLANTED. ON 26 JULY 2018 THE MEDICAL AFFAIRS MANAGER MADE THE FOLLOWING ANALYSIS: EARLY INFECTION IN A HINGED TKA, 2 MONTHS AFTER IMPLANTATION. 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 REVIEW PERFORMED ON 25 JULY 2018: LOT 173074: 13 ITEMS MANUFACTURED AND RELEASED ON 03 OCTOBER 2017. EXPIRATION DATE: 2022-09-17. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW PERFORMED ON 25 JULY 2018 ON THE OTHER EXPLANTED DEVICES: GMK-REVISION OFFSET CONNECTOR 5 MM, REF. (B)(4), LOT. 172194 ((B)(4) ): 100 ITEMS MANUFACTURED AND RELEASED ON 21 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-28. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 81 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION EXTENSION STEM - FLUTED Ø 15 L 105, REF. (B)(4), LOT. 172183 ((B)(4)): 15 ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2017. EXPIRATION DATE: 2022-06-25. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION FEMUR PS #5 L, REF. (B)(4), LOT. 148149 ((B)(4)): 18 ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2014. EXPIRATION DATE: 2019-11-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION OFFSET CONNECTOR 3 MM, REF. (B)(4), LOT. 177104 ((B)(4)): 50 ITEMS MANUFACTURED AND RELEASED ON 10 JANUARY 2018. EXPIRATION DATE: 2022-12-17. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 29 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION EXTENSION STEM - FLUTED Ø 18 L 105, REF. (B)(4), LOT. 162551 ((B)(4)): 30 ITEMS MANUFACTURED AND RELEASED ON 05 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-24. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION FEMORAL WEDGE DISTAL # 5/8MM, REV. (B)(4), LOT. 173129 ((B)(4)): 27 ITEMS MANUFACTURED AND RELEASED ON 19 JULY 2017. EXPIRATION DATE: 2022-07-02. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION FEMORAL WEDGE DISTAL # 5/4MM, REF. (B)(4), LOT. 162592 ((B)(4)): 26 ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016 EXPIRATION DATE: 2021-07-03. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION CENTRED 3DMETAL TIBIAL CONE S H20, REF. (B)(4), LOT. 163587 ((B)(4)): 48 ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2016. EXPIRATION DATE: 2021-11-24. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION FIXED TIBIAL INSERT SC # 5/14MM, CODE: (B)(4), LOT. 170570 ((B)(4)): 15 ITEMS MANUFACTURED AND RELEASED ON 27 MARCH 2017. EXPIRATION DATE: 2022-03-07. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 5 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 INFECTION 9 MONTHS AFTER THE PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention