BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 36

    MDR report key: 18021383 · Received October 27, 2023

    Report

    Report Number
    3005180920-2023-00848
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    October 4, 2023
    Report Date
    October 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809347
    PMA / PMN Number
    K131518
    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 2310834: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUN-2023. EXPIRATION DATE: 2028-05-20. 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. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON (B)(6) 2023: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G (K103721) LOT 2241228: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2022. EXPIRATION DATE: 2027-11-10. 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 PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. AT ABOUT 3 WEEKS FROM PRIMARY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433685 BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 36 HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 2310834 07630030809347

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention