BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX PROSTHESIS HEAD 12/14 32MM S

    MDR report key: 5818049 · Received July 23, 2016

    Report

    Report Number
    3005673311-2016-00114
    Event Type
    Malfunction
    Date Received
    July 23, 2016
    Date of Event
    June 24, 2016
    Report Date
    December 18, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    LWJ
    PMA / PMN Number
    K060918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. EVALUATION: ON GOING.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE QUALITY SPECIFICATIONS FOR THE BALL HEAD, THE MATERIAL PROPERTIES CORRESPOND TO THE SPECIFICATIONS THAT WERE VALID AT THE TIME OF MANUFACTURE. THERE ARE NO INDICATIONS OF A MATERIAL DEFECT.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). THREE YEAR_TEN MONTH POST-OPERATIVE PRONOUNCED CAPSULE ADHESIONS. FIRST SURGERY (B)(6) 2007. REVISION SURGERY (B)(6) 2011. ADDITIONAL COMPONENTS TO BE EVALUATED ARE INCLUDED IN CONCOMITANT SECTION OF REPORT INCLUDE: NC081T / METHA SHORT HIP STEM P SIZE 1, LOT NUMBER: 51385443, PRODUCTION DATE: 05/23/2007, EXPIRATION DATE: 04/30/2011. NC089K / METHA NECK 12/14 135DEG/7.5DEG L RETRO-R ANTE, LOT NUMBER: 51381260, PRODUCTION DATE: 01/23/2007, EXPIRATION DATE: 12/31/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471013 BIOLOX PROSTHESIS HEAD 12/14 32MM S MPLANTS STANDARD PROSTHESES HE LWJ AESCULAP IMPLANT SYSTEMS NK560 51413356

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other