BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD

    MDR report key: 5765032 · Received July 1, 2016

    Report

    Report Number
    3005180920-2016-00325
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 3, 2016
    Report Date
    September 7, 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

    THE IMPLANTS INVOLVED INVOLVED IN THIS COMPLAINT ARE A VERSAFITCUP AND A QUADRA-H. NO INFORMATION WILL BE AVAILABLE CONCERNING PRODUCTS REFERENCES AND CODE NUMBERS BEFORE THE REVISION SURGERY, AS CONFIRMED BY THE INITIAL REPORTER ON (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 08 AUGUST 206 AND INCLUDES: THE REVISION SURGERY WAS NEEDED DUE TO THE FOLLOWING PROBLEMS: THIGH PAIN, STRESS SHIELDING, LOOSENING STEM, AND TOO MUCH CUP ANTEVERSION. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 31 AUGUST 206 AND INCLUDES: REFERENCES AND LOT NUMBERS OF THE PRODUCTS INVOLVED IN THE COMPLAINT. BATCH REVIEWS PERFORMED ON 31 AUGUST 2016. LOT 072253: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 NOVEMBER 2007. EXPIRATION DATE: 2012-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT. VERSAFITCUP ACETABULAR SHELL CC LIGHT DIAM 54, CODE 01.26.54MBTL, LOT. 081680 (NOT MARKETED IN USA). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 AUGUST 2008. EXPIRATION DATE: 2013-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED DUE TO WRONG POSITIONING OF THE CUP AND STRESS SHIELDING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419348 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 072253

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention