BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12923753 · Received December 3, 2021

    Report

    Report Number
    3005180920-2021-00950
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 3, 2021
    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 · 0

    BATCH REVIEW PERFORMED ON 11 NOVEMBER 2021: LOT 1909763: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-MAR-2020. EXPIRATION DATE: 2025-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 11 NOVEMBER 2021: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E LOT. 1903448 (K103721) LOT 1903448: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-05-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824476 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.210 1909763 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention