BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-P COLLARED QUADRA-P COLLARED STD STEM SIZE 1

    MDR report key: 15680512 · Received October 27, 2022

    Report

    Report Number
    3005180920-2022-00823
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    October 11, 2022
    Report Date
    October 27, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040731850
    PMA / PMN Number
    K192827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 OCTOBER 2022: LOT 2114286: (B)(4) MANUFACTURED AND RELEASED ON 09-FEB-2022. EXPIRATION DATE: 2027-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 17 OCTOBER 2022: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 2200854. LOT 2200854: (B)(4) MANUFACTURED AND RELEASED ON 10-MAY-2022. EXPIRATION DATE: 2027-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH FROM THE PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480610 STEM: QUADRA-P COLLARED QUADRA-P COLLARED STD STEM SIZE 1 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.12.161 2114286 07630040731850

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention