BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 Ø 28 SIZE L

    MDR report key: 12998729 · Received December 14, 2021

    Report

    Report Number
    3005180920-2021-00995
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 24, 2021
    Report Date
    December 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809149
    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 30 NOVEMBER 2021. LOT 2007622: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2020. EXPIRATION DATE: 2025-OCT-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 30 NOVEMBER 2021: LINER: MPACT DM 01.32.4248MC DM CONVERTER LINER F/DM (K131458), LOT 2006526: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-2020. EXPIRATION DATE: 2025-NOV-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900308 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 Ø 28 SIZE L CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.203 2007622 07630030809149

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention