BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON ANT CONS TIB INS 9MMD

    MDR report key: 3112631 · Received May 14, 2013

    Report

    Report Number
    0002249697-2013-01672
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K915512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REVISION DUE TO WEAR INVOLVING A DURACON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION INDICATED THAT. REVIEW OF THE PROVIDED MEDICAL RECORDS DID NOT INCLUDE ANYTHING OF NOTE TO THE INVESTIGATION. INSUFFICIENT INFORMATION WAS PROVIDED TO MAKE A MEANINGFUL DICTATION. DEVICE HISTORY REVIEW NOT PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. COMPLAINT HISTORY REVIEW NOT PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE EXPLANTED DEVICE, REVISION OPERATIVE REPORT, AND X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF AN INSERT AND A PATELLA ON THE LEFT KNEE. THE IMPLANTS HAVE BEEN IMPLANTED SINCE 1997, THEY REVISED BECAUSE OF NORMAL WEAR AND TEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF AN INSERT AND A PATELLA ON THE LEFT KNEE. THE IMPLANTS HAVE BEEN IMPLANTED SINCE 1997, THEY REVISED BECAUSE OF NORMAL WEAR AND TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212668 DURACON ANT CONS TIB INS 9MMD IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention