BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULOX HEAD, S, 32/-3.5, TAPER 12/14

    MDR report key: 7198852 · Received January 17, 2018

    Report

    Report Number
    0009613350-2018-00108
    Event Type
    Injury
    Date Received
    January 17, 2018
    Date of Event
    September 29, 2017
    Report Date
    May 17, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE YET THE DEVICE, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON JANUARY 15, 2018 TO THE APPROPRIATE REPRESENTATIVES. ¿ LOT NUMBER OF THE SULOX HEAD ¿ SURGICAL REPORT OF IMPLANTATION ¿ ALL AVAILABLE X-RAYS DURING TIME IN- VIVO WITH PRINT DATE ¿ WAS THE SURGEON ABLE TO FIND OUT, WHERE THE METAL RING CAME FROM? A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4). THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E BIOLOX FORTE HEAD REF# 12.28.05) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED.

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION OF THE COMPLAINT IT HAS BEEN NOTICED THAT THE CERAMIC HEAD IS NOT MANUFACTURED BY ZIMMER (B)(4), (B)(6). LEGAL MANUFACTURER IS ZIMMER INC., (B)(6), (SPLIT CASE REGISTERED UNDER (B)(4), (B)(4)). THIS COMPLAINT WILL BE INVALIDATED FROM THE SYSTEM. INVESTIGATION OF THE CERAMIC HEAD WILL BE DONE IN SPLIT CASE REGISTERED UNDER (B)(4). THEREFOR THIS MDR IS OBSOLETE. PLEASE INVALIDATE THE CASE FROM YOUR SYSTEM. (B)(4).

    Description of Event or Problem · 1

    A USER REPORT FROM (B)(6) AUTHORITY WAS RECEIVED ON OCTOBER 06, 2017 FOR WHICH THE CASE (B)(4) WAS OPENED AND REPORTED BY ZIMMER INC., (B)(4). ON JANUARY 09, 2018 IT BECAME AWARE THAT SULOX HEAD WAS ALSO IMPLANTED. THE CASE AT HAND WAS CREATED. IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A SULOX HEAD ON (B)(6) 2006 ON THE RIGHT HIP SIDE AND UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO INLAY WEAR AND PRESENCE OF A FOREIGN BODY (METAL RING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46132 SULOX HEAD, S, 32/-3.5, TAPER 12/14 NA LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R