BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE L

    MDR report key: 10127320 · Received June 8, 2020

    Report

    Report Number
    3005180920-2020-00314
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    May 11, 2020
    Report Date
    August 6, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 MAY 2020: LOT 1905651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2019. EXPIRATION DATE: 2024-10-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 22 MAY 2020: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER 36/E (K103721) LOT 185986: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2018. EXPIRATION DATE: 2023-09-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE STEM ON (B)(6) 2020. THE SURGEON REVISED THE HEAD AND STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. MEDACTA COMPLAINT (B)(4) WAS FILED [MDR 3005180920-2020-00295]. PRESENTLY, ONE MONTH AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591963 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE L HIP CERAMIC FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.210 1905651 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention