BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L

    MDR report key: 16253504 · Received January 27, 2023

    Report

    Report Number
    3005180920-2023-00002
    Event Type
    Injury
    Date Received
    January 27, 2023
    Date of Event
    December 28, 2022
    Report Date
    January 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 JANUARY 2023: LOT: 2002615: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JULY-2020. EXPIRATION DATE: 2025-07-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 03 JANUARY 2023: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT: 2010633: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2021. EXPIRATION DATE: 2026-01-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD INSTABILITY ON BOTH SIDES OF THE HIP. ONCE UNDER ANESTHESIA SURGEON STRESSED THE JOINT UNDER FLUORO AND DETERMINED THAT BOTH HIPS NEEDED LENGTHENING. THE SAME DAY OF PRIMARY THE SURGEON REVISED THE HEAD ON BOTH SIDES OF THE HIP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409136 BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.210 2002615 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention