BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD 28/0 'M' 8/10

    MDR report key: 2792310 · Received October 12, 2012

    Report

    Report Number
    9613350-2012-00959
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE RETRIEVAL DID NOT REVEAL ANY PRODUCT DEFECTS BESIDES SOME SIGN OF WEAR. WITH THE INFORMATION AND THE INVESTIGATION RESULT, IT IS STILL NOT SUSPECTED THAT A PRODUCT FAILURE LEAD TO THE REPORTED EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THERE IS NO NEED FOR FURTHER CORRECTIVE MEASURES AT THIS POINT IN TIME. ZIMMER (B)(4) WILL CONSIDER THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN (B)(6) FEMALE PATIENT RECEIVED A DURASUL COCR HEAD ON (B)(6) 2004. ON (B)(6) 2012 SHE UNDERWENT A REVISION SURGERY DUE TO WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COCR HEAD 28/0 'M' 8/10 FEMORAL HEAD KWY ZIMMER GMBH 2217312

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R