BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULOX-HEAD 28 S 12/14

    MDR report key: 3911548 · Received May 27, 2014

    Report

    Report Number
    9613350-2014-03556
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT YET RECEIVE THE DEVICES, BUT AS MENTIONED BY COMPLAINANT, THEY WILL BE AVAILABLE AND SENT BACK FOR INVESTIGATION. X-RAYS AND SURGICAL REPORTS WERE PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT WAS IMPLANTED ON (B)(6) 2006 WITH A SULOX-HEAD 28 'S' 12/14 ON THE RIGHT SIDE. ON FOLLOW UP X-RAYS TAKEN IN (B)(6) 2012 NO ANOMALIES WERE SEEN. THEN ON FOLLOW UP X-RAYS TAKEN ON (B)(6) 2014, A FRACTURE OF THE CERAMIC HEAD WAS DETECTED. THE REVISION SURGERY HAS TAKEN PLACE ON (B)(6) 2014 DUE TO THE FRACTURE OF THE CERAMIC HEAD. IT IS ALSO REPORTED THAT THE FRACTURE OF THE CERAMIC HEAD OCCURRED DUE TO WEARING A HEAVY LOAD, NO TRAUMA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311024 SULOX-HEAD 28 S 12/14 CERAMIC FEMORAL HEAD SYSTEM LZO ZIMMER GMBH NA 2321198

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R