BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE M 36MM +5

    MDR report key: 2961496 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-12369
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. REG. # 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES WAS PERFORMED BY (B)(4) USING A STEREOMICROSCOPE AND SCANNING ELECTRON MICROSCOPIC (SEM) AND ENERGY-DISPERSIVE X-RAY SPECTROSCOPY (EDS) ANALYSIS ON THE FEMORAL NECK TAPER SURFACE OF THE STEM. THE ARTICULAR SURFACES OF THE FEMORAL HEAD AND ACETABULAR APPEAR UNREMARKABLE WITH LIGHT SCRATCHING ON BOTH. SEVERAL AREAS OF GOUGING / BURNISHING / PLASTIC DEFORMATION ARE SEEN AT THE BASE OF THE NECK TAPER. IT IS ASSUMED THAT THESE MARKINGS WERE CREATED DURING IMPLANT REMOVAL. THE FEMORAL NECK TAPER SHOWS AREAS OF DISCOLORATION AND BLACK DEBRIS SUGGESTIVE OF FRETTING CORROSION DEPOSITS. DEPOSITS ARE ALSO SEEN ON THE LATERAL ASPECT OF THE FEMORAL NECK, DISTAL TO THE HEAD-NECK TAPER JUNCTION. (B)(4). AN X-RAY EDS SPECTRUM AND ELEMENTAL MAPS FROM A TYPICAL AREA OF CORROSION DEPOSITS ON THE NECK TAPER. EDS ANALYSIS SUGGESTS THAT THE DEPOSITS CONTAINS PRIMARILY OXIDES OF CHROMIUM AND MOLYBDENUM. THE FEMORAL HEAD TAPER SHOWS BLACK CORROSION DEPOSITS AND IMPRINTING OF THE GROOVE PATTERN OF THE FEMORAL NECK DEEP WITHIN THE TAPER. DARK CORROSION DEPOSITS ARE SEEN ON THE CHAMFERED SURFACE THAT LEADS INTO THE MOUTH OF THE FEMALE TAPER. (B)(4). X-RAY EDS ANALYSIS WAS NOT PERFORMED ON THE FEMORAL HEAD TAPER AS ITS RESTRICTED GEOMETRY OF INHIBITS ANALYSIS WITHIN IT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE STEM OR HEAD PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE SEARCH FOUND ONE OTHER REPORT AGAINST THE 246309 LOT CODE FOR PAIN. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO INFECTION AND PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66090 ARTICUL/EZE M 36MM +5 FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. REG. # 8010379 2424742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention