BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0

    MDR report key: 18083904 · Received November 7, 2023

    Report

    Report Number
    3005180920-2023-00858
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809163
    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 16 OCTOBER 2023: LOT 2103144: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2021. EXPIRATION DATE: 2026-06-11. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2023. LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C (K103721) LOT 2211263: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2022. EXPIRATION DATE: 2027-06-13. 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. THE PATIENT OF THIS MDR IS THE SAME OF MDR 2022-00874. IN THIS MDR WE ARE REPORTING THE PATIENT DOB, AGE AND WEIGHT BECOME NOW AVALIBLE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350279 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2103144 07630030809163

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention