BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M

    MDR report key: 19889681 · Received August 1, 2024

    Report

    Report Number
    3005180920-2024-00587
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    July 14, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    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 31-JUL-2024 LOT 2402159: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2024. EXPIRATION DATE: 2029-01-21. 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 31-JUL-2024 LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28 (K092265) LOT 2307734: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2023. EXPIRATION DATE: 2028-05-28. 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

    AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE HEAD AND LINER HAVE BEEN REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912122 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 2402159

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention