BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS FEMORAL STEM SIZE 5 STD

    MDR report key: 5290041 · Received December 11, 2015

    Report

    Report Number
    3005180920-2015-00321
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 11, 2015
    Report Date
    March 10, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09 FEBRUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 10 FEBRUARY 2016, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DETAILS RECEIVED ON (B)(6) 2015: THE PATIENT HAD A POOR CONDITION, AFTER THE PRIMARY SURGERY; A FEW DAYS AFTER, THE PATIENT HAD AN INFECTION, THE SURGEON PERFORMED A WASH OUT WITHOUT SOLVING COMPLETELY THE PROBLEM. AFTER THAT THE SURGEON PERFORMED THE REVISION SURGERY. EXPLANTS ARE NOT AVAILABLE. ON (B)(6) 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING COMMENT WHILE REVIEWING THE X-RAY: EARLY INFECTION ON A PATIENT IN POOR GENERAL CONDITION. NO REASON TO SUSPECT THAT THE PROBLEM IS PRODUCT RELATED. INFECTIONS ARE A KNOWN POSSIBLE COMPLICATION OF DEPP SURGERY. BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 151858: (B)(4) MANUFACTURED AND RELEASED ON (B)(4) 2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. COCR BALL HEAD 12/14 Ø 32 SIZE L CODE (B)(4) LOT. 114025 ((B)(4)): (B)(4) MANUFACTURED AND RELEASED ON (B)(4) 2012. EXPIRATION DATE: 2016-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. FLAT EDGE FULL PE CEMENTED CUP Ø 32 / # 56 CODE (B)(4)LOT. 111680 (NOT CLEARED NOR MARKETED IN THE USA): (B)(4) MANUFACTURED AND RELEASED ON (B)(4)2011. EXPIRATION DATE: 2016-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    HIP REVISION ON (B)(6) 2015 BECAUSE OF INFECTION: (B)(6). ALL IMPLANTS HAVE BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819552 QUADRA H CEMENTLESS FEMORAL STEM SIZE 5 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 151858

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention