BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L

    MDR report key: 18965632 · Received March 23, 2024

    Report

    Report Number
    3005180920-2024-00147
    Event Type
    Injury
    Date Received
    March 23, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 22, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 FEBRUARY 2024. LOT 2005402: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-09-2020. EXPIRATION DATE: 2025-08-30. 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. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 28 FEBRUARY 2024. LINER: VERSAFITCUP CC TRIO 01.26.3244HCT FLAT PE HC LINER Ø 32 / E (K103352) LOT 2213349: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JULY-2022. EXPIRATION DATE: 2027-07-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR LEG LENGTH DISCREPANCY AT ABOUT 1 YEAR AND 2 MONTHS FROM PRIMARY. HEAD AND LINER REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701040 BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L HIP DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2005402 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention