BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2

    MDR report key: 8883100 · Received August 12, 2019

    Report

    Report Number
    3005180920-2019-00672
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 17, 2019
    Report Date
    November 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802140
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 30TH 2019 WE HAVE RECEIVED THE ITME INVOLVED IN THE COMPLAINT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FEMORAL STEM SHOWS SIGNS OF EXTRACTION ON THE NECK REGION AND COATING RESIDUALS ON THE PROXIMAL FRONTAL, MEDIAL AND LATERAL PARTS.

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION: HIP REVISION SURGERY PERFORMED 5 YEARS AND 5 MONTHS AFTER TOTAL HIP ARTHROPLASTY IN A YOUNG, ACTIVE MAN ((B)(6) YEAR OLD). RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES AROUND THE STEM AND THE FORMATION OF PEDESTAL. THE STEM LOOKS SLIGHTLY UNDERSIZED. THE REASON OF THIS CHOICE IS UNKNOWN: PATIENT ANATOMY AND BONE MORPHOLOGY MAY BE ONE REASON BUT THIS CANNOT BE CONFIRMED NOT HAVING PREOPERATIVE X-RAYS. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 19-07-2019: LOT 070675/T: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2019. EXPIRATION DATE: 2016-12-31. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2013. EXPIRATION DATE: 2018-10-31. IN BOTH CASES, 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.

    Description of Event or Problem · 1

    THE PATIENT RETURNED WITH PAIN AND RADIOGRAPHIC EVIDENCE OF PROXIMAL LUCENCY, DISTAL TIP BONE INGROWTH ONLY. THE PATIENT WAS QUITE ACTIVE VERY EARLY ON FOLLOWING THE PRIMARY SURGERY AND THIS, ALONG WITH THE TIGHT DISTAL FEMORAL CANAL (DORR TYPE A) MAY HAVE CONTRIBUTED TO THE REASON FOR REVISION. SURGEON REVISED THE HIP, STEM AND HEAD WERE REMOVED ALMOST 5 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON JULY 15 WE WERE INFORMED ABOUT THE REVISION SURGERY THAT WAS PERFORMED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679700 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 070675/T 07630030802140

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention