BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 21146987 · Received January 14, 2025

    Report

    Report Number
    3005180920-2024-01157
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 DECEMBER 2024. LOT 2216031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2022. EXPIRATION DATE: 2027-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 23 DECEMBER 2024 LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2217703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2022. EXPIRATION DATE: 2027-09-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012218 MECTACER BIOLOX DELTA FEMORAL BALL HEAD FEMORAL HEAD Ø 36 SIZE L LZO MEDACTA INTERNATIONAL SA 01.29.210 2216031 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention