BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L

    MDR report key: 12179429 · Received July 16, 2021

    Report

    Report Number
    3005180920-2021-00606
    Event Type
    Injury
    Date Received
    July 16, 2021
    Date of Event
    June 29, 2021
    Report Date
    July 16, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809149
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 JULY 2021: LOT 174694: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-GEN-2018. EXPIRATION DATE: 2023-01-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 08 JULY 2021: BALL HEADS: BIPOLAR HEAD 25060.2846 BIPOLAR HEAD ¿28X46 (K091967) LOT 1908064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2019. EXPIRATION DATE: 2024-11-27. 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 · 1

    1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079082 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.203 174694 07630030809149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention