BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS STEM #5 STD

    MDR report key: 4812198 · Received May 29, 2015

    Report

    Report Number
    3005180920-2015-00108
    Event Type
    Injury
    Date Received
    May 29, 2015
    Report Date
    September 4, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2015: LOT 145665: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10/29/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 112458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10/21/2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 05/11/2015 IT WAS CONFIRMED THAT THERE WAS NO SIMILAR EVENT ON INVOLVING THE STERILIZATION LOT NUMBER OF THE CUP AND OF THE STEM. ON 05/26/2015 IT WAS CONFIRMED THAT NO IMPLANTS WILL BE AVAILABLE FOR ANALYSIS. ON 05/16/2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING COMMENT: THIS IS REPORTED TO BE AN INFECTION ON A RECENTLY IMPLANTED THA THAT WAS ACHIEVING GOOD OSSEOINTEGRATION. INFECTION IS A KNOWN COMPLICATION OF THA AND, APART FROM LOOKING AT BATCH DATA, I SEE NO ACTION REQUIRED FROM THE DEVICE POINT OF VIEW.

    Description of Event or Problem · 1

    IMP REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350815 QUADRA H CEMENTLESS STEM #5 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1