BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE 132 SIZE 5.5

    MDR report key: 2912799 · Received January 7, 2013

    Report

    Report Number
    9616680-2013-90018
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "THIS PT HAD UNDERGONE RIGHT HIP REPLACEMENT IN 2010. IMPLANT USED WAS UNCEMENTED ACCOLADE STEM AND TRIDENT CUP (STRYKER) WITH 36 MM COBALT CHROME HEAD AND CROSSLINKED POLYETHYLENE LINER. DURING THE POSTOPERATIVE PERIOD, THE PROSTHESIS SUBSIDED, AND AS A RESULT HIS LEG WAS SHORTER BY APPROX 20 MM. THE OFFSET APPEARED NOT RECONSTRUCTED AT THE INITIAL SURGERY. THE PT WAS SEEN IN THE (B)(6) 2012. HE HAD SIGNIFICANT DIFFICULTIES WALKING DUE TO HIS LEG LENGTH DIFFERENCE. AFTER OBTAINING MEDICAL RECORDS FROM THE ORIGINAL HOSPITAL, WE OPTED TO REVISE THE HIP REPLACEMENT TO RESTORE LEG LENGTH AND OFFSET. AS A ROUTINE PREOPERATIVE INVESTIGATION, A HIP JOINT NEEDLE ASPIRATE WAS OBTAINED WHICH RETURNED WHITE MILKY FLUID TYPICAL OF METAL DEBRIS REACTION. METAL ION LEVELS WERE RAISED (CHROMIUM 1.14 MICROGRAMS/L, COBALT 2.40 MICROGRAMS/L). THE FLUID SAMPLE WAS FROZEN AND NOT PROCESSED. AN MRI RULED OUT SEVERE ALVAL. INTRAOPERATIVELY DURING THE REVISION SURGERY, A RELATIVELY LARGE AMOUNT OF WHITE MILKY FLUID WAS DRAINED. THE PROSTHESIS WAS WELL FIXED. ON REMOVAL OF THE MODULAR 36 MM HEAD, CORROSION AT THE TRUNION/HEAD TAPER JUNCTION WAS EVIDENT. PHOTOS WERE TAKEN. THE PROSTHESIS WAS REMOVED AS PLANNED, AND A NEW ONE INSERTED WHICH RECONSTRUCTED LEG LENGTH AND OFFSET FULLY. IT IS UNUSUAL FOR A METAL-ON-POLYETHYLENE ARTICULATION TO PRODUCE A SUFFICIENTLY LARGE AMOUNT OF METAL ION DEBRIS TO ELICIT A LOCAL REACTION; AND TO RAISE BLOOD LEVELS. THE PROBLEM COULD BE DUE TO THE SMALL DIAMETER OF THE TRUNION RELATIVE TO THE HEAD DIAMETER, WHICH WOULD GENERATE SIGNIFICANT TORSIONAL FORCES AT THE HEAD/TRUNION INTERFACE. METAL DEBRIS REACTION AND CORROSION OF THE TRUNION/HEAD TAPER JUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8112 ACCOLADE 132 SIZE 5.5 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 28250903

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R