BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

    MDR report key: 20143061 · Received September 5, 2024

    Report

    Report Number
    3005180920-2024-00707
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809163
    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 16-AUG-2024 LOT 2404438: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2024. EXPIRATION DATE: 2029-02-19. 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. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 16-AUG-2024: CUP: VERSAFITCUP CC TRIO 01.26.45.1148 ACETABULAR SHELL CC TRIO NO-HOLE Ø 48 (K122911) LOT 2343953: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2023. EXPIRATION DATE: 2028-12-03. 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. LINER: MECTACER 01.29.408 CERAMIC LINER Ø 32 / C LOT 2404456: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2024. EXPIRATION DATE: 2029-02-21. 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. (ITEM NOT REGISTERED IN US)

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF JOINT LUXATION CAUSED BY INSTABILITY. LINER, BALL HEAD AND CUP REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900360 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 2404438 07630030809163

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention