BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULOX-HEAD 28 'L' 12/14

    MDR report key: 2081395 · Received April 29, 2011

    Report

    Report Number
    9613350-2011-00283
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    October 5, 2010
    Report Date
    December 13, 2006
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE REC'D FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT PRODUCT FAILURE LEAD TO THE ALLEGED EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT REVISION DUE TO BREAKAGE OF THE SULOX HEAD. IT IS ALSO REPORTED THAT PT JUMPED FROM A CHAIR ("CONTROLLED") AND HEARD/FELT A CRACKING. FIRST CHECK AT LOCAL DOCTOR DID NOT REVEAL THE BREAKAGE OF THE IMPLANT. THE PT WORKED AS USUAL UNTIL THE BREAKAGE WAS DETECTED SOME MONTHS LATER. REVISION WAS DONE IN (B)(6) 2011: EXCHANGE OF HEAD, INLAY, AND ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SULOX-HEAD 28 'L' 12/14 BIOLOX OPTION CERAMIC FEMORAL HEAD SYS LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O