BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 21183995 · Received January 17, 2025

    Report

    Report Number
    3005180920-2024-01135
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    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 20-12-2024: LOT 2315550: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-06-2023. EXPIRATION DATE: 2028-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: LINER: IMPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2309707: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-07-2023. EXPIRATION DATE: 2028-06-05. 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. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 36MM HEAD WITH ANOTHER 36MM HEAD, AND REVISED THE FLAT PE HC LINER WITH A FACE CHANGING LINER AND ADDED AN OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908071 MECTACER BIOLOX DELTA FEMORAL BALL HEAD BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S LZO MEDACTA INTERNATIONAL SA 01.29.208 2315550 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female Required Intervention