BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOLOX DELTA HEAD, 12/14, 36 X 0

    MDR report key: 3978812 · Received June 30, 2014

    Report

    Report Number
    9613350-2014-03676
    Event Type
    Other
    Date Received
    June 30, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. X-RAYS, OR OTHER SOURCE DOCUMENTS WERE PROVIDED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AN FOUND TO BE CONFORMING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THE CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT WAS IMPLANTED ON (B)(6) 2014 WITH A BIOLOX DELTA HEAD, 12/14, 36 X 0 AS A COMPONENT OF THE THA ON THE RIGHT SIDE. IT IS ALSO REPORTED THAT ON A FOLLOW UP VISIT ON (B)(6) 2014 PATIENT STATES HE IS DOING FAIRLY WELL, COMPLAINING ONLY OF SOME STIFFNESS AT NIGHT. PATIENT HAS NOT YET REVISED YET, NEITHER IS A REVISION SURGERY PLANNED. PATIENT BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380814 BIOLOX DELTA HEAD, 12/14, 36 X 0 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH NA 2711326

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other