BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOLOX DELTA CER HEAD 40 12/14

    MDR report key: 2891200 · Received December 13, 2012

    Report

    Report Number
    9613350-2012-01164
    Event Type
    Other
    Date Received
    December 13, 2012
    Date of Event
    April 19, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES AS THEY ARE STILL IMPLANTED. NEITHER WERE X-RAYS, OR OTHER SOURCE DOCUMENTS RECEIVED FOR REVIEW. FOR THE LOT NUMBER RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER, THERE IS NO INDICATION FOR A PRODUCT FAILURE. 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 CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED UNEXPLAINED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX DELTA CER HEAD 40 12/14 NONE LZO ZIMMER GMBH 2618045

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other