BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SHP CUP

    MDR report key: 6844538 · Received September 6, 2017

    Report

    Report Number
    3002806535-2017-00881
    Event Type
    Death
    Date Received
    September 6, 2017
    Report Date
    September 5, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. PETERS, R.M. (2017). FATAL COBALT TOXICITY AFTER A NON-METAL-ON-METAL TOTAL HIP ARTHROPLASTY. MANUSCRIPT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2017-00880.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, A PATIENT WAS INDICATED FOR HIP REVISION DUE TO SIGNS OF METAL WEAR DEBRIS AND PSEUDOTUMOR; HOWEVER, THE REVISION WAS POSTPONED DUE TO ISCHEMIC CEREBROVASCULAR ACCIDENT. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL TWO WEEKS LATER DUE TO PAIN, VOMITING AND DIARRHEA. THE PATIENT REPORTED ASYMMETRICAL HEARING LOSS, VISUAL IMPAIRMENT, COMPLAINTS OF VERTIGO, AND UNINTENTIONAL WEIGHT LOSS. WITHIN 2 DAYS, THE PATIENT DETERIORATED AND SUBSEQUENTLY DIED. IT WAS HYPOTHESIZED IN THE JOURNAL ARTICLE THAT DUE TO THIRD BODY WEAR REACTION BETWEEN CERAMIC REMNANTS AND THE METAL FEMORAL HEAD SEVERE AND ULTIMATELY FATAL COBALT TOXICITY OCCURRED WITH DILATED CARDIOMYOPATHY AND NEUROTOXICITY (HEARING LOSS AND VISUAL IMPAIRMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626330 UNKNOWN SHP CUP PROSTHESIS, HIP KWA BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O UNKNOWN HEAD| UNKNOWN STEM