BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S

    MDR report key: 10763153 · Received October 30, 2020

    Report

    Report Number
    3005180920-2020-00769
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 3, 2020
    Report Date
    October 30, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 OCTOBER 2020: LOT 1910890: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUNE-2020. EXPIRATION DATE: 2025-05-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 107 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER ÿ32/D LOT. 2001303 (K103721), BATCH REVIEW PERFORMED ON 14 OCTOBER 2020: LOT 2001303: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2020. EXPIRATION DATE: 2025-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 42 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 3 DAYS AFTER PRIMARY FOR IMPLANT DISLOCATION, HEAD FROM LINER. THE SURGEON REVISED SUCCESSFULLY THE JOINT STEM, HEAD AND LINER. THE SURGEON EXPRESSED AN OPINION THAT THE ROOT CAUSE OF THIS EVENT WAS LESS OFFSET LENGTH CAUSED BY THE MIS-SELECTION OF THE IMPLANT SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228717 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 1910890 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention