BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 54OD

    MDR report key: 3010174 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-14023
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES BY DEPUY MATERIALS SCIENCE FINDS NO MATERIAL DEFECTS WERE OBSERVED. WHITE-LIGHT STEREOMICROSCOPY WAS PERFORMED. THE DISTAL PORTION OF THE HIP STEM TAPER AND ITS MATING SURFACE ON THE FEMORAL HEAD TAPER EXHIBITED BLACK REGIONS, CONSISTENT WITH CORROSION. SCANNING ELECTRON MICROSCOPY (SEM) WAS USED TO EXAMINE THE FEMORAL HEAD TAPER AND THE HIP STEM TAPER. THE DISTAL PORTIONS OF THE MATING TAPER SURFACES HAD THE APPEARANCE OF A RESIDUE OR DEPOSIT PRESENT. ELEMENTAL ANALYSIS WAS PERFORMED WITH THE SEM COUPLED WITH ENERGY DISPERSIVE X-RAY SPECTROSCOPY (EDS), AND INDICATED THE RESIDUE WAS METALLIC OXIDE ((B)(4)), CONSISTENT WITH CORROSION. WITH SEM, PITTING AND OTHER SURFACE FEATURES CONSISTENT WITH CORROSION WERE OBSERVED ON THE TAPER SURFACES. THE PREVIOUSLY PROVIDED CROSS-SECTION SAMPLES WERE RE-POLISHED AND METAL LOGRAPHICALLY ETCHED FOR MICROSTRUCTURAL EXAMINATION. (B)(4). NO EVIDENCE OF MICROSTRUCTURAL DEFECTS WAS OBSERVED FOR EITHER MATERIAL. THE DEVICE HISTORY RECORDS FOR THE S-ROM HIP STEM AND THE FEMORAL HEAD WERE REVIEWED. NO MANUFACTURING DEVIATIONS OR ABNORMITIES WERE FOUND. NO APPARENT REASON FOR THE CORROSION OBSERVED WAS IDENTIFIED. NO ADDITIONAL INFORMATION INCLUDING X-RAYS OR DEMOGRAPHICS WERE PROVIDED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS REGARDING THE REPORTED PSEUDOTUMOR AND PAIN WITH THE INFORMATION PROVIDED. 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.

    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

    THE PATIENT WAS REVISED DUE TO PSEUDOTUMOR. THE PATIENT HAD A SEVERE PAIN IN THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113399 ULTAMET MTL INS NEUT 36MM 54OD METAL INSERT KWA 8010379 DEPUY INTL., LTD. 2231514

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention