BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 21364687 · Received February 12, 2025

    Report

    Report Number
    3005180920-2025-00062
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    January 20, 2025
    Report Date
    February 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809255
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24-JAN-2025. LOT 2119474: 40 ITEMS MANUFACTURED AND RELEASED ON 12-APR-2022. EXPIRATION DATE: 28-MAR-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 37 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: CUP: MPACT 01.32.156DH ACETABULAR SHELL Ø56 TWO-HOLES (K132879) LOT 2300109: 31 ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2023. EXPIRATION DATE: 13-MAY-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 30 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K103721), LOT 2304472: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2023. EXPIRATION DATE: 19-MAR-2028. 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. STEM: SMS SOLID COLLARED 01.36.152 SMS COLLARED SOLID STEM STD SIZE 12 (K203041), LOT 2206145: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2022. EXPIRATION DATE: 01-SEP-2027. 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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965227 MECTACER BIOLOX DELTA FEMORAL BALL HEAD BALL HEADS: MECTACER 01.29.214 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE L LZO MEDACTA INTERNATIONAL SA 01.29.214 2119474 07630030809255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention