BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL WEDGE DISTAL SIZE 5/4MM

    MDR report key: 9115747 · Received September 25, 2019

    Report

    Report Number
    3005180920-2019-00794
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    August 26, 2019
    Report Date
    December 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-DEC-2019. LOT 188150: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2017. EXPIRATION DATE: 14.10.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.604FDW FEMORAL WEDGE DISTAL SIZE 6/4MM LOT. 177679 (K102437). BATCH REVIEW PERFORMED ON 06-DEC-2019. LOT 177679: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2018. EXPIRATION DATE: 14.02.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.2405L FEMUR REVISION PS SIZE 5 L LOT. 186389 (K102437). BATCH REVIEW PERFORMED ON 06-DEC-2019. LOT 186389: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2018. EXPIRATION DATE: 05.11.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0412SCF FIXED TIBIAL INSERT SC SIZE 4/12MM LOT. 183192 (K103170). BATCH REVIEW PERFORMED ON 06-DEC-2019. LOT 183192: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2018. EXPIRATION DATE: 27.06.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FCL16150 EXTENSION STEM - FLUTED Ø 16 L 150 LOT. 145056 (K120790). BATCH REVIEW PERFORMED ON 06-DEC-2019. LOT 145056: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2014. EXPIRATION DATE: 30.09.2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2019. ON (B)(6) 2017, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS POSITIVE FOR MRSA. THE SURGEON REVISED ALL MEDACTA HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND COMPLAINT (B)(4) WAS FILED. ON (B)(6) 2018, THE PATIENT HAD RECEIVED NEW IMPLANTS. ON (B)(6) 2019, THE PATIENT CAME IN REPORTING PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REVISED THE FEMORAL COMPONENT, STEM, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND COMPLAINT (B)(4) WAS FILED. FOLLOWING THIS ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS MSRA. THE SURGEON LEFT ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER, THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THIS COMPLAINT (B)(4) WAS FILED. EIGHT (8) WEEKS LATER, THE PATIENT HAD PERMANENT HARDWARE IMPLANTED.

    Description of Event or Problem · 1

    14 DAYS AFTER SURGERY, THE PATIENT WAS REVISED DUR TO FEMORAL COMPONENT LOOSENING, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, THE PATHOGEN IS (B)(6). THE SURGEON LEFT ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER, THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915020 FEMORAL WEDGE DISTAL SIZE 5/4MM FEMORAL WEDGE JWH MEDACTA INTERNATIONAL SA 188150

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention