BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 20485135 · Received October 18, 2024

    Report

    Report Number
    3005180920-2024-00842
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809224
    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 30 SEPTEMBER 2024 LOT 2311918: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUN-2023. EXPIRATION DATE: 2028-05-29. 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. OTHER DEVICE INVOLVED: LINER: MPACT HOODED PE HC LINER Ø36/F (K132879) LOT 2308601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19- MAY-2023. EXPIRATION DATE: 2028-05-07. 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

    THE PATIENT HAD PAIN DUE TO A LUXATION OF THE HEAD FROM THE LINER. AT ABOUT 1 MONTHS POST PRIMARY THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010218 MECTACER BIOLOX DELTA FEMORAL BALL HEAD HIP HEAD LZO MEDACTA INTERNATIONAL SA 01.29.211 2311918 07630030809224

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention