BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL STEM 75X10MM FLUTED

    MDR report key: 1822517 · Received August 27, 2010

    Report

    Report Number
    1818910-2010-05756
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K063633
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCTS CONFIRMED THE REPORTED EVENT. THE INVESTIGATION CONCLUDED THE REPORTED EVENT WAS DESIGN RELATED. PRA/ HHE WAS CONDUCTED ON THIS REPORTED EVENT AS WELL AS ALL INFORMATION WILL BE TRACKED AND DOCUMENTED THOUGH CAPA (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED PAIN AND SWELLING AFTER INSERTION OF DUOFIX FEMUR, ON REVISION METALLOSIS SEEN ALL IMPLANTS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL STEM 75X10MM FLUTED JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS NA CC44PL4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention