BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL 52

    MDR report key: 10137533 · Received June 10, 2020

    Report

    Report Number
    3005180920-2020-00322
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 7, 2020
    Report Date
    January 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807893
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D DEPRTMENT: VISUAL INSPECTION PERFORMED ON 15-DEC-2020. EXCEPT FOR THE SIGNS RELATED TO THE EXTRACTION, NO EVIDENT SIGNS OF LOOSENING WERE FOUND ON THE STEM. FROM THE RECEIVED COMPONENTS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT,BUT WE CAN EXCULDE A FAILURE OF THE DEVICE. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPRTMENT: 11 YEARS AFTER CEMENTLESS PRIMARY THA BOTH FEMORAL AND ACETABULAR COMPONENTS ARE FOUND LOOSE AND REPLACED. THE STEM APPEARS IN VARUS POSITION BUT THIS WAS THE SITUATION ALSO POSTOPERATIVELY IN 2009. THE CUP IS IN A RAREFIED BONE AREA, AND AGAIN THIS WAS THE CASE SINCE PRIMARY SURGERY. HOWEVER, BONE QUALITY AND CONDITIONS HAVE DETERIORATED OVER THE YEARS, PROBABLY CREATING THE LOOSENING CONDITIONS. WE CANNOT IDENTIFY OTHER POTENTIAL CAUSES OR ANOMALIES FROM THE IMAGES SUPPLIED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 MAY 2020: LOT 082588: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2008. EXPIRATION DATE: 2013-09-30. 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 SINCE 1-1-2016. OTHER DEVICE INVOLVED IN THE EVENT: STEM: QUADRA-H 01.12.034 CEMENTLESS, HA COATED LAT STEM SIZE 4 LOT. 082238 (K082792). BATCH REVIEW PERFORMED ON 25 MAY 2020: LOT 082238: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-0CT-2008. EXPIRATION DATE: 2013-09-30. 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 SINCE 1-1-2016.

    Description of Event or Problem · 1

    REVISION SURGERY FOR STEM AND CUP LOOSENING ABOUT 11 YEARS AFTER PRIMARY SURGERY. RADIOLUCENCY WAS PRESENT WITHOUT A MECHANICAL CAUSE. NO INFECTION DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604569 CUP: VERSAFITCUP ACETABULAR SHELL 52 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 01.26.45.1152 07630030807893

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention