BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 2860835 · Received December 6, 2012

    Report

    Report Number
    1818910-2012-83230
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK083642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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

    THE SUBMITTED IMPLANTS WERE NON-DESTRUCTIVELY EVALUATED AFTER STERILIZATION BY AUTOCLAVE STEAM DISINFECTION. STEREO-MICROSCOPIC EXAMINATION WAS PERFORMED ON THE IMPLANTS AND SCANNING ELECTRON MICROSCOPIC (SEM) AND ENERGY-DISPERSIVE X-RAY SPECTROSCOPY (EDS) ANALYSIS WERE PERFORMED ON THE FEMORAL NECK TAPER SURFACE OF THE STEM AND A REGION ON THE PROXIMAL PORTION OF THE STEM THAT HAD MATED WITH THE SLEEVE. DURING STEREO-MICROSCOPIC EXAMINATION THE EXTENT OF FRETTING AND CORROSION ON THE TAPER SURFACES OF THE FEMORAL NECK AND THE FEMORAL HEAD BORE WAS QUALITATIVELY ASSESSED USING THE QUALITATIVE CRITERIA FOR CORROSION AND FRETTING SCORES SCHEME DEVELOPED BY (B)(4). THE ARTICULAR SURFACES OF THE FEMORAL HEAD AND METAL INSERT APPEAR UNREMARKABLE TO THE UN-AIDED EYE WITH MILD SCRATCHING AND NO VISIBLE SIGNS OF ACCELERATED WEAR. A GROUP OF SCRATCHES THAT ARE BELIEVED TO BE ASSOCIATED WITH IMPLANT REMOVAL DURING REVISION SURGERY ARE SEEN ON THE FEMORAL HEAD. A SMALL AREA OF DARK STAINING IS SEEN ON THE FEMORAL STEM. EDS INDICATES THAT THIS DEPOSIT CONTAINS (B)(4), SUGGESTING THAT IT IS NOT A CORROSION DEPOSIT FROM FRETTING OF THE STEM AND SLEEVE. A REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. X-RAYS RECEIVED AND REVIEWED. X-RAYS ARE NOT DATED. IMPLANT APPEARS TO BE PLACED IN PROPER POSITION. IT CANNOT BE DETERMINED, WITH THE X-RAYS PROVIDED, THAT THE COMPLAINT IS PRODUCT RELATED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO PSEUDO TUMOR AND CORROSION BETWEEN STEM HEAD JUNCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX50OD DEPUY HIP IMPLANT KWA DEPUY INTERNATIONAL 3078760

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention