BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4

    MDR report key: 6511315 · Received April 21, 2017

    Report

    Report Number
    3005180920-2017-00197
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 21, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 21 APRIL 2017. LOT 163455: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAV EBEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFIT CUP FLAT PE HC LINER Ø 36 / E, CODE 01.26.3644HCT, LOT. 164468 (K120531) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 SEPTEMBER 2016. EXPIRATION DATE: 2021-09-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO INFECTION TO RIGHT HIP. INFECTION IS CONFIRMED. THE PATIENT RECEIVED A WASHOUT AND HEAD AND LINER CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293069 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 163455

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention