BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4140319 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03749
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    January 1, 1995
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION INVOLVING AN UNKNOWN KNEE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. -DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. -COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER, LOT CODE, SPECIFIC DEVICE DESCRIPTION AND REASON FOR THE REVISION WERE NOT PROVIDED. THE DEVICE IS AN UNKNOWN RIGHT KNEE. THE SALES REPRESENTATIVE WAS TOLD THAT THE SURGEON THAT HE BELIEVED THE PATIENT HAD A PREVIOUS KNEE REVISION IN 1995. THE SALES REP CONFIRMED THAT THE HOSPITAL WOULD NOT ALLOW HIM TO ACCESS ANY OF THE PATIENT'S MEDICAL RECORDS TO CLARIFY THIS REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REP THAT PATIENT HAD REVISION OF RIGHT KNEE IN 1999. SALES REP IS UNAWARE OF THE REASONS. 09/17/2014: ADDITIONAL CONVERSATION WITH THE SALES REP INDICATED THAT THE SURGEON BELIEVED THAT THE PATIENT HAD A REVISION IN 1995 BUT HE WAS UNCERTAIN IF STRYKER DEVICES WERE REVISED AT THAT TIME. THE DETAILS OF THESE REVISIONS ARE NOT CLEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REP THAT PATIENT HAD REVISION OF RIGHT KNEE IN 1999. SALES REP IS UNAWARE OF THE REASONS. ON 09/17/2014: ADDITIONAL CONVERSATION WITH THE SALES REP INDICATED THAT THE SURGEON BELIEVED THAT THE PATIENT HAD A REVISION IN 1995 BUT HE WAS UNCERTAIN IF STRYKER DEVICES WERE REVISED AT THAT TIME. THE DETAILS OF THESE REVISIONS ARE NOT CLEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REP THAT PATIENT HAD REVISION OF RIGHT KNEE IN 1999. SALES REP IS UNAWARE OF THE REASONS. ON (B)(6) 2014: ADDITIONAL CONVERSATION WITH THE SALES REP INDICATED THAT THE SURGEON BELIEVED THAT THE PATIENT HAD A REVISION IN 1995 BUT HE WAS UNCERTAIN IF STRYKER DEVICES WERE REVISED AT THAT TIME. THE DETAILS OF THESE REVISIONS ARE NOT CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619086 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R