BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M

    MDR report key: 12475443 · Received September 15, 2021

    Report

    Report Number
    3005180920-2021-00744
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    August 18, 2021
    Report Date
    September 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 AUGUST 2021: LOT 186531: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2018. EXPIRATION DATE: 2023-NOV-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 25 AUGUST 2021: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 (K092265) LOT 1810744: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-FEB-2019. EXPIRATION DATE: 2024-JAN-21. 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

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 2 YEARS AND 3 MONTHS 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
    1372573 MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.202 186531 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention