BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT

    MDR report key: 5991588 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00503
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    September 1, 2016
    Report Date
    January 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 28 DECEMBER 2016 AND INCLUDES: IT WAS PERFORMED THE SECOND STEP REVISION, THE ANTIBIOTIC SPACER WAS REMOVED AND PUT IN THE FINAL IMPLANTS SUCCESSFULLY. THE INFECTION HAS CLEARED UP AND THE SURGEON WAS HAPPY WITH THE OUTCOME.

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT HAD THE PRIMARY KNEE ON (B)(6) 2016. THEN, AN I&D AND POLY SWAP WAS PERFORMED ON (B)(6) 2016 AS THE PATIENT WAS (B)(6) FOR (B)(6). ON 23 SEPTEMBER 2016 THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: SECOND INFECTION IN SAME PATIENT, SAME SITE AFTER FEW WEEKS FROM PREVIOUS INTERVENTION. INFECTIONS ARE 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 28 SEPTEMBER 2016. LOT 155592: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 DECEMBER 2015. EXPIRATION DATE: 2020-11-21. 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-PRIMARY FEMUR CEMENTED STD SIZE 5 STD NARROW / LEFT, CODE 02.07.2015L, LOT. 155295 (K122232) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-31. 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-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM, CODE 02.07.0412FUC, LOT. 143619 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 SEPTEMBER 2014. EXPIRATION DATE: 2019-08-31. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT TESTED (B)(6) FOR (B)(6). THE SURGEON REVISED ALL HARDWARE AND INPUT AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643516 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 155592

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention