BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1

    MDR report key: 8230879 · Received January 9, 2019

    Report

    Report Number
    3005180920-2018-01076
    Event Type
    Injury
    Date Received
    January 9, 2019
    Date of Event
    December 10, 2018
    Report Date
    October 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802133
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER VISUAL INSPECTION PERFORMED ON 23RD SEPTEMBER 2019. THE HA COATING OF THE STEM WAS ALMOST TOTALLY ABSORBED AND LOTS OF SCRATCHES WERE VISIBLE IN THE NECK REGION, PROBABLY SOME OCCURRED DURING THE REVISION; ANYWAY, IT IS NOT CLEAR IF SOME OF THESE SCRATCHES ARE RELATED TO IMPINGEMENT WITH OTHER PRODUCTS, AS THE COMPETITOR'S CUP GEOMETRY IS UNKNOWN. FROM THE RECEIVED PIECE IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, BUT IT COULD BE RELATED TO THE COMPETITOR'S CUP.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019: LOT 050833: 24 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2005. EXPIRATION DATE: (B)(6) 2010. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 13 YEARS AFTER PRIMARY DUE TO PERI-PROSTHETIC METALLOSIS ON THE PROXIMAL PART OF THE STEM AND ON THE PERIPHERY OF THE NON-MEDACTA CUP. NO INVASION OF THE JOINT CAPSULE. LINER AND HEAD WERE CERAMIC IMPLANTS. THE SURGEON REVISED THE STEM WITH A QUADRA R SIZE 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24773 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 050833 07630030802133

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention