BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE EXTENSION STEM - FLUTED Ø 15 L 65

    MDR report key: 8816203 · Received July 23, 2019

    Report

    Report Number
    3005180920-2019-00596
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    June 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030822995
    PMA / PMN Number
    K120790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON (B)(6), THE PATIENT HAD PERMANENT HARDWARE IMPLANTED AND HAD THE ANTIBIOTIC SPACER REMOVED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 5 JULY 2019: LOT 162544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 AUGUST 2016. EXPIRATION DATE: 2021-07-27. 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. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 5 JULY 2019: GMK-SPHERE 02.12.0025L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L (K140826) LOT. 178702. LOT 178702: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5 MARCH 2018. EXPIRATION DATE: 2023-02-09. 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-REVISION 02.07.0685L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 5 L (K123721) LOT. 180458 LOT 180458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 APRIL 2018. EXPIRATION DATE: 2023-04-05. 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 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L (K121416) LOT. 183026. LOT 183026: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 APRIL 2018. EXPIRATION DATE: 2023-06-24. 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-REVISION 02.09.TA510 TIBIAL AUGMENTATION SIZE 5/10MM (K130299) LOT. 146738. LOT 146738: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 NOVEMBER 2014. EXPIRATION DATE: 2019-09. 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-REVISION 02.09.TA510 TIBIAL AUGMENTATION SIZE 5/10MM (K130299) LOT. 148091. LOT 148091: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MARCH 2015. EXPIRATION DATE: 2020-01. 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

    1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT COMPLAINT OF INSTABILITY AND ASEPTIC LOOSENING OF THE TIBIAL TRAY AND SUBSEQUENTLY, THE SURGEON REVISED THE TIBIAL TRAY AND POLY, COMPLAINT WAS FILED. 24 DAYS AFTER THE FIRST REVISION SURGERY HAS BEEN PERFORMED THE SECOND REVISION SURGERY DUE TO AND INFECTION ((B)(6)). THE SURGEON SUBSEQUENTLY PERFORMED A WASHOUT AND A POLY SWAP ON (B)(6) 2018, COMPLAINT WAS FILED. PRESENTLY, 4 MONTHS FROM THE SECOND REVISION SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608755 GMK-SPHERE EXTENSION STEM - FLUTED Ø 15 L 65 EXTENSION STEM FLUTED JWH MEDACTA INTERNATIONAL SA 162544 07630030822995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention