BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.212 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S

    MDR report key: 17036591 · Received June 1, 2023

    Report

    Report Number
    3005180920-2023-00380
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    May 3, 2023
    Report Date
    June 1, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809231
    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 (B)(6)2023 LOT 2217243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2022. EXPIRATION DATE: 2027-10-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641) LOT 2246667: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JAN-2023. EXPIRATION DATE: 2028-01-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AFTER THE PRIMARY HIP SURGERY, IN POST-OP RECOVERY, THE PATIENT SUFFERED A JOINT LUXATION. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683051 BALL HEADS: MECTACER 01.29.212 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S HIP DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.212 2217243 07630030809231

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention