BEUDAMED
    FDA Adverse Event Other Summary report: N

    CO-CR HD 12/14 +4 NECK 38MM

    MDR report key: 2253155 · Received August 30, 2011

    Report

    Report Number
    9613350-2011-00562
    Event Type
    Other
    Date Received
    August 30, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    PMA / PMN Number
    778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO 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. THE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SHOULD ADDITIONAL INFO 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 STATED THAT HE HAS RIGHT HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CO-CR HD 12/14 +4 NECK 38MM INTER-OP DURASUL ACETABULAR INSERTS/CO JDI ZIMMER, INC. 2305002

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other