BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK

    MDR report key: 9400844 · Received December 3, 2019

    Report

    Report Number
    3005180920-2019-01015
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 6, 2019
    Report Date
    January 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802621
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: HA LAYER ABSORBED, SIGNS OF EXTRACTION ON FEMORAL NECK. IT IS NOT POSSIBLE TO DETERMINE AN IMPLANT RELATED FAILURE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11-NOV-2019. LOT 143469: 20 ITEMS MANUFACTURED AND RELEASED ON 29-JUL-2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. 5 YEARS AFTER PRIMARY CEMENTLESS THA THE STEM IS REMOVED DUE TO PAIN. AT REOPERATION, THE SURGEON REPORTEDLY REMARKED THAT OSSEOINTEGRATION HAD NOT TAKEN PLACE IN A SATISFACTORY FASHION, AND THIS IS PROBABLY THE CAUSE FOR PAIN AND HENCE REVISION. ACCORDING TO REPORT, THIS PATIENT NEVER FELT COMFORTABLE WITH HER THIGH, SO A POSSIBLE EXPLANATION IS THAT SOMETHING MAY HAVE PREVENTED THE STEM FROM FINDING A GOOD INITIAL STABILITY THAT ALLOWS OSSEOINTEGRATION. WITH THE INFORMATION AT HAND, ONLY UNSUPPORTED HYPOTHESES CAN BE MADE ON THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 5 YEARS AFTER THE PRIMARY DUE TO STEM SUBSIDENCE. THE QUADRA STEM WAS REMOVED VIA A POSTERIOR APPROACH, THE SURGEON COMMENTED THAT IT HAD NOT BONDED. A MINIMAX STEM WAS USED TO COMPLETE THE REVISION SURGERY WITH A NEW CERAMIC HEAD. A SMALL AMOUNT OF BONE GRAFT DISTALLY WAS ALSO USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199209 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 143469 07630030802621

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention