BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINECTIV MODULAR NECK

    MDR report key: 5681924 · Received May 26, 2016

    Report

    Report Number
    0001822565-2016-01767
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    April 27, 2016
    Report Date
    January 11, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK063251
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED. PHOTOGRAPHS OF X-RAYS SHOW THE HIP CONSTRUCT WITH NORMAL ALIGNMENT UPRIGHT AND IN ROTATION. THE PHOTOGRAPH OF THE EXPLANTS SHOWS THAT THE LINER WAS FRACTURED INTO SEVERAL PIECES DURING EXPLANTATION. THE TAPER OF THE EXPLANTED NECK AND HEAD SHOW DARK COLORATION, SUGGESTING CORROSION. DHR REVIEW SHOWS NO DEVIATIONS OR ANOMALIES IN THE MANUFACTURING PROCESS. THESE DEVICES ARE USED FOR TREATMENT. IT WAS CONFIRMED THAT THE DEVICE WAS USED IN AN APPROVED AND COMPATIBLE COMBINATION. THE ORIGINAL HIP IMPLANT SURGERY WAS PERFORMED WITHOUT COMPLICATION. IT IS NOT KNOWN WHAT THE PATIENT ACTIVITY LEVEL IS, NOR IF THEY ADHERED TO REHABILITATION PROTOCOL. PATIENT IS NOTED TO HAVE EXCELLENT BONE QUALITY. ON (B)(6) 2015, A FOLLOW UP LEFT HIP MRI WAS PERFORMED. MRI RESULTS REVEALED MODERATE SIZED LOBULATED FLUID COLLECTION WITHIN THE ILIOPSOAS BURSA WITH AREAS OF HETEROGENEOUS SIGNAL EVIDENT. THE MEDICAL PROFESSIONAL ALLEGES THAT THIS MAY REFLECT PARTICLE DISEASE. THERE WAS NO FLUID COLLECTION AT THE JOINT, NO MUSCLE OR TENDON ABNORMALITIES, AND NO HIP JOINT EFFUSION. CHROMIUM ION LEVELS WERE DETERMINED TO BE APPROXIMATELY 2.1 UG/L, AND COBALT ION LEVELS WERE APPROXIMATELY 5.6 UG/L. REVISION OPERATIVE NOTES COULD NOT BE OBTAINED. SURGEON ALLEGES CORROSION OF THE DEVICES EXPLANTED. BASED ON THE INFORMATION PRESENTED, IT IS LIKELY DEVICE CORROSION HAS LED TO THE ONSET OF PARTICLE DISEASE, HOWEVER A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UPDATED 510(K): K063251.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO ELEVATED COBALT AND CHROMIUM LEVELS. CORROSION WAS DISCOVERED AROUND THE HEAD/NECK JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338385 KINECTIV MODULAR NECK KWA KWA ZIMMER, INC. N/A 60964129

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R