BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3

    MDR report key: 15734901 · Received November 4, 2022

    Report

    Report Number
    3005180920-2022-00810
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 5, 2022
    Report Date
    November 4, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802041
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 6 OCTOBER 2022: LOT 2111450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2022. EXPIRATION DATE: 2027-JAN-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D MANAGER: DURING THE ANALYSIS IT IS EVALUATED THAT ALL THE HA COATING IS PRESENT ON THE STEM BODY. ONLY ONE SMALL PART ON THE LATERAL STEM IS LITTLE BIT SCRATCHED. THIS IS EXPECTABLE DUE THE FACT THAT THE STEM HAS BEEN EXPLANTED AFTER 2 DAYS. SOME SIGNS AND SCRATCHES ARE PRESENT ON THE NECK SURFACE PROBABLY DUE TO REVISION SURGERY. WE EVALUATED THE SHAPE AND DIMENSION OF THE STEM COMPARING IT WITH DEDICATED X-RAY TEMPLATES 100% SCALE AND ALL PARAMETERS ARE IN COMPLIANCE TO THE SPECIFICATIONS. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF REPORTED COMPLAINT.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 2 DAYS AFTER THE PRIMARY SURGERY DUE TO A PERIPROSTHETIC FRACTURE, FOR REASONS UNKNOWN. STEM AND HEAD HAVE BEEN REVISED. SALES REP COMMENT: THE STEM WAS UNDERSIZED. A SIZE 2 WAS PLANNED, AND THEN A SIZE 3 HAS BEEN IMPLANTED. BUT EVEN A SIZE 4 WOULD HAVE BEEN UNDERSIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335067 STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3 HIP CEMENTLESS, HA COATED STD STEM JDI MEDACTA INTERNATIONAL SA 01.12.023 2111450 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention