BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4

    MDR report key: 15797028 · Received November 15, 2022

    Report

    Report Number
    3005180920-2022-00865
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    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-NOV-2022. LOT 2204268: (B)(4). EXPIRATION DATE: 2027-05-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 159 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY 1 MONTH AFTER THE PRIMARY. THE SURGEON PUT AN XXL HEAD THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199422 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 HIP ACETABULAR CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 2204268 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention