BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION ALL POLY PAT LG

    MDR report key: 4221767 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04130
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K936292
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION/MIGRATION INVOLVING A DURACON PATELLA WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION NOT PERFORMED, DEVICE WAS DISCARDED AT THE HOSPITAL. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT COULD NOT CONFIRM THE EVENT NOR DETERMINE A ROOT CAUSE. -DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN DURACON ASYMMETRICAL ALL POLY PATELLA; LARGE SIZE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED BY THEATRE STAFF AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATELLA REVISED (B)(6) 2014 BY DR (B)(6) AS PATIENT WAS COMPLAINING OF KNEE PAIN. DR (B)(6) HAD TO REVISE A DURACON PATELLA THAT HAD MIGRATED AND RUPTURED THE QUADRICEPS TENDON. PROSTHESIS IMPLANTED AT RPA HOSPITAL APPROX 10 YEARS AGO.

    Description of Event or Problem · 1

    PATELLA REVISED (B)(6) 2014 BY DR (B)(6) AS PATIENT WAS COMPLAINING OF KNEE PAIN. DR (B)(6) HAD TO REVISE A DURACON PATELLA THAT HAD MIGRATED AND RUPTURED THE QUADRECEPS TENDON. PROSTHESIS IMPLANTED AT RPA HOSPITAL APPROX 10 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703796 DURA DURATION ALL POLY PAT LG IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 00032552

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention