BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX CERAMIC HEAD 36MM + 0

    MDR report key: 1972191 · Received January 7, 2011

    Report

    Report Number
    9613350-2011-00012
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    September 29, 2010
    Report Date
    December 14, 2010
    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. THEREFORE NO INVESTIGATION COULD BE ACCOMPLISHED. AS NO LOT NUMBERS WERE PROVIDED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 GMBH CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. IT IS ALSO REPORTED THAT POST OP, PT EXPERIENCED PAIN AND DISLOCATION AND WAS REVISED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX CERAMIC HEAD 36MM + 0 BIOLOX OPTION CERAMIC FEMORAL HEAD SYS LZO ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention