BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5

    MDR report key: 16435302 · Received February 24, 2023

    Report

    Report Number
    3005180920-2023-00115
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    January 27, 2023
    Report Date
    February 24, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802171
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08-FEB-2023: LOT 2011443: (B)(4) MANUFACTURED AND RELEASED ON 22-FEB-2021. EXPIRATION DATE: 2026-02-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL MANAGER: REVISION 1 MONTH AFTER PRIMARY THA ON A MALE PATIENT DUE TO JOINT LUXATION. THE PATIENT HAD A PRIMARY HIP SURGERY AFTER A FALL AND CONSEQUENT FEMORAL BONE FRACTURE. FROM THE RADIOGRAPHIC IMAGE PROVIDED, THE STEM SEEMS UNDERSIZED AND SUBSIDED WHICH MAY HAVE CAUSED THE ADVERSE EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY REVISING THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD, AND REVISING THE MEDACTA CUP AND LINER WITH A NEW MEDACTA CUP AND LINER. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT HAD A PRIMARY HIP SURGERY AFTER A FALL AND CONSEQUENT FEMORAL BONE FRACTURE. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING A JOINT LUXATION. THE SURGEON NOTICED THAT THE STEM APPEARED TO BE UNDERSIZED AND HAD SIGNIFICANT SUBSIDENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY REVISING THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD, AND REVISING THE MEDACTA CUP AND LINER WITH A NEW MEDACTA CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058238 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.035 2011443 07630030802171

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention