BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-P COLLARED STD STEM SIZE 0

    MDR report key: 19094609 · Received April 12, 2024

    Report

    Report Number
    3005180920-2024-00228
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 20, 2024
    Report Date
    April 12, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040731843
    PMA / PMN Number
    K192827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27-MAR-2024: LOT 2200482: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2022. EXPIRATION DATE: 2027-05-30. 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. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 27-MAR-2024: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT 2335090: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2023. EXPIRATION DATE: 2028-08-15. 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.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA STEM AND HEAD AND COMPETITOR LINER AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833001 QUADRA-P COLLARED STD STEM SIZE 0 HIP STEM LZO MEDACTA INTERNATIONAL SA 2200482 07630040731843

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention